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Assessment of the efficacy and accuracy of cervical cytology screening with the Hologic Genius Digital Diagnostics System 用Hologic Genius数字诊断系统评估宫颈细胞学筛查的有效性和准确性
IF 3.2 3区 医学 Q3 ONCOLOGY Pub Date : 2025-06-21 DOI: 10.1002/cncy.70022
Esther Elishaev MD, Lakshmi Harinath MD, Yuhong Ye MD, PhD, Jonee Matsko SCT, MB, Amy Colaizzi SCT, Stephanie Wharton SCT, Rohit Bhargava MD, Liron Pantanowitz MD, PhD, MHA, Matthew G. Hanna MD, Sarah Harrington PhD, Chengquan Zhao MD, PhD

Background

Medical technologies powered by artificial intelligence are quickly transforming into practical solutions by rapidly leveraging massive amounts of data processed via deep learning algorithms. There is a necessity to validate these innovative tools when integrated into clinical practice.

Methods

This study evaluated the performance of the Hologic Genius Digital Diagnostics System (HGDDS) with a cohort of 890 previously reviewed and diagnosed ThinPrep Papanicolaou (Pap) tests with the intent to deploy this system for routine clinical use. The study included all diagnostic categories of The Bethesda System, with follow-up tissue sampling performed within 6 months of abnormal Pap test results to serve as the ground truth.

Results

The HGDDS demonstrated excellent performance in detecting significant Pap test findings, with close to 100% sensitivity (98.2%–100%) for cases classified as atypical squamous cells of undetermined significance and above within a 95% confidence interval and a high negative predictive value (92.4%–100%).

Conclusions

The HGDDS streamlined workflow, reduced manual workload, and functioned as a stand-alone system.

人工智能驱动的医疗技术通过快速利用深度学习算法处理的大量数据,正在迅速转化为实用的解决方案。有必要在整合到临床实践时验证这些创新工具。本研究对Hologic Genius数字诊断系统(HGDDS)的性能进行了评估,研究对象为890例先前审查和诊断的ThinPrep Pap试验,目的是将该系统应用于常规临床应用。该研究包括Bethesda系统的所有诊断类别,并在6个月内对异常巴氏试验结果进行随访组织取样,以作为基本事实。结果HGDDS在检测显著的巴氏试验结果方面表现优异,在95%的置信区间内,对未确定显著性及以上的非典型鳞状细胞的敏感性接近100%(98.2%-100%),阴性预测值较高(92.4%-100%)。结论HGDDS简化了工作流程,减少了人工工作量,可以作为一个独立的系统使用。
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引用次数: 0
Untangling the mystery of rising breast cancer rates 解开乳腺癌发病率上升的谜团
IF 3.2 3区 医学 Q3 ONCOLOGY Pub Date : 2025-06-19 DOI: 10.1002/cncy.70026
Bryn Nelson PhD, William Faquin MD, PhD
<p>After invasive breast cancer rates declined sharply in the early 2000s, clinicians cheered what seemed to be a major trend. The drop paralleled a big decline in the use of hormone replacement therapy among postmenopausal women after an influential study—the Women’s Health Initiative—found an association between estrogen–progesterone therapy and an increased risk of breast cancer and heart disease.<span><sup>1</sup></span></p><p>The overall incidence, however, soon leveled off and then began to rise again, with troubling increases over the decade ending in 2021, especially among women younger than 50 years and those of Asian American/Pacific Islander (AAPI) or Hispanic heritage. The highest relative increase, in fact, has occurred among women in their 20s and 30s. Researchers have launched investigations into a complex stew of mitigating and contributing factors—from increases in obesity and alcohol consumption to shifting reproductive patterns and earlier ages at first menstruation—but have yet to determine which are playing the biggest roles.</p><p>Although overall mortality rates continue to fall, they remain elevated for Native American and Alaska Native women in particular and for Black women. Changing that dynamic may require not only untangling the complex mix of molecular and environmental risk factors but also improving mammography methods and expanding access to medical care for underserved populations.</p><p>One of the biggest challenges has been understanding which factors are influencing breast cancer rates across the board and which are associated with particular risk groups. According to a 2024 report led by researchers at the American Cancer Society (ACS), the upswing in estrogen or progesterone receptor–positive (hormone receptor–positive) malignancies accounted for most of the recent increase in breast cancer incidence (the ACS publishes <i>Cancer Cytopathology</i>).<span><sup>2</sup></span></p><p>The first author, Angela N. Giaquinto, MSPH, an associate scientist II in the ACS Surveillance Research Program, says that changing reproductive patterns have likely contributed to that upturn. “Having fewer children and/or having children later in life increases breast cancer risk by increasing lifetime exposure to estrogen, which is the driver for most breast cancers,” she explains. “However, pregnancy has a dual effect on breast cancer risk; risk is increased during pregnancy and in the first 5 years following childbirth and is only reduced after about 2 decades compared to those who have not given birth.”</p><p>That seemingly contradictory risk pattern may be mediated by changing hormone levels during and after pregnancy. Although the hormone levels likely play a role in the increased postpartum risk, Giaquinto says, “the biological mechanism is not fully understood.”</p><p>Adetunji T. Toriola, MD, PhD, MPH, a professor of surgery and a breast cancer researcher in the Division of Public Health Sciences at Washington University in
在21世纪初浸润性乳腺癌发病率急剧下降后,临床医生们为这似乎是一个主要趋势而欢呼。在一项有影响力的研究——妇女健康倡议——发现雌激素-黄体酮治疗与乳腺癌和心脏病风险增加之间存在关联之后,绝经后妇女中激素替代疗法的使用也出现了大幅下降。然而,总体发病率很快趋于平稳,然后又开始上升,在截至2021年的十年间出现了令人不安的增长,特别是在50岁以下的女性和亚裔美国人/太平洋岛民(AAPI)或西班牙裔女性中。事实上,相对增幅最大的是20多岁和30多岁的女性。研究人员已经开始对一系列复杂的缓解和促进因素进行调查——从肥胖和酒精消费的增加,到生殖模式的转变和初潮年龄的提前——但还没有确定哪些因素起着最大的作用。尽管总体死亡率继续下降,但美洲土著和阿拉斯加土著妇女特别是黑人妇女的死亡率仍然很高。改变这种动态可能不仅需要解开分子和环境风险因素的复杂组合,还需要改进乳房x光检查方法,并扩大服务不足人群获得医疗保健的机会。最大的挑战之一是了解哪些因素全面影响乳腺癌发病率,哪些因素与特定的风险群体有关。根据美国癌症协会(ACS)研究人员2024年的一份报告,雌激素或孕激素受体阳性(激素受体阳性)恶性肿瘤的上升是近期乳腺癌发病率增加的主要原因(ACS出版癌症细胞病理学)。该研究的第一作者安吉拉·n·贾昆托(Angela N. Giaquinto)是MSPH,也是美国癌症学会监测研究项目的副科学家。她说,生殖模式的改变可能是导致这种上升的原因。她解释说:“少生孩子和/或晚生孩子会增加一生中雌激素的暴露,从而增加患乳腺癌的风险,这是大多数乳腺癌的驱动因素。”“然而,怀孕对乳腺癌风险有双重影响;在怀孕期间和分娩后的头5年,风险会增加,与没有生育的人相比,只有在大约20年后,风险才会降低。”这种看似矛盾的风险模式可能是通过怀孕期间和怀孕后激素水平的变化来调节的。贾昆托说,尽管激素水平可能在产后风险增加中起作用,但“生物学机制尚未完全了解。”addetunji T. Toriola,医学博士,公共卫生科学博士,圣路易斯华盛顿大学公共卫生科学系的外科教授和乳腺癌研究员,注意到每一次分娩都能降低大约10%的乳腺癌风险。事实上,在有五个以上孩子的女性身上观察到的保护作用最大。考虑到大家庭越来越不常见,托里奥拉博士说,这一现象提出了一个有趣的问题:“女性如何仍能从与生育经验相关的风险降低中受益?我们能否将其应用于降低风险,尤其是年轻女性?”托里奥拉博士补充说,最近第一次月经的平均年龄越来越小的趋势也可能是导致乳腺癌发病率上升的原因之一,尽管原因尚不清楚。早发性乳腺癌,技术上定义为在45岁以下的成年人中被诊断出的癌症,通常无法被初步发现,因为它们出乎意料。2024年,日益增长的危险促使美国预防服务工作组将常规乳房x光检查的推荐起始年龄从50岁改为40岁。癌症种类的相对丰度也会随着年龄的增长而变化。尽管生长缓慢的雌激素受体阳性或孕激素受体阳性乳腺癌在老年妇女中更为常见,但侵袭性her2相关和激素受体阴性/ her2阴性(三阴性)乳腺癌在年轻妇女中更为常见。与此同时,众所周知的BRCA基因突变仅占大约五分之一的早发病例。总体而言,乳腺癌在老年女性中仍然更为常见,但年轻女性正开始缩小这一差距。2024年美国癌症学会的报告显示,在过去十年中,50岁以下女性的乳腺癌发病率比老年女性高2倍(每年1.4%对0.7%)。托里奥拉博士和他的同事进行的另一项研究同样发现,乳腺癌在年轻女性中显著增加。他说:“最值得注意的是,这种增长是在所有种族和民族群体中出现的。” 在过去的20年里,他和他的同事发现,在20 - 49岁的女性中,雌激素受体阳性、I期和IV期肿瘤的发病率都有所增加,而同一年龄组中雌激素受体阴性、II期和III期肿瘤的发病率则有所下降。雌激素受体阴性肿瘤的总体减少也同样难以解释,尽管这种差异向托里奥拉博士提出了另一个诱人的问题:“我们能否从雌激素阴性肿瘤的减少中吸取教训,以减轻雌激素阳性肿瘤的增加?”托里奥拉博士的研究小组的初步研究表明,20岁至39岁女性的乳腺癌死亡率最近有所改善,尽管仍高于40岁至49岁女性的死亡率——这一差异在所有种族和族裔群体中都有体现托里奥拉博士也认为,由于相对缺乏筛查,更有可能发展为更具侵袭性的癌症,而诊断延误,这可能是导致这群妇女死亡率上升的共同原因。其他明显的模式也出现了。尽管体重在各个年龄段都在增加,“超重只会增加绝经后妇女患乳腺癌的风险,所以不会增加年轻妇女的发病率,”贾昆托说。“虽然超重和乳腺癌之间的关系尚不完全清楚,但脂肪组织会产生雌激素,从而增加患乳腺癌的风险,同时增加炎症。”亚洲女性肥胖率最低,而黑人女性肥胖率最高。研究发现了酒精相关风险的不同模式。贾昆托指出,饮酒约占乳腺癌的16%,30多岁和40多岁女性的酗酒率有所上升。白人和美洲印第安人或阿拉斯加土著成年人重度饮酒的比例(8%)高于黑人(4%)、西班牙裔(4%)或亚洲成年人(2%)“也有更多的证据表明,使用化学头发松弛剂或永久性染发剂也与风险增加有关,尤其是在更有可能使用这些产品的黑人女性中,”贾昆托说。托里奥拉博士称护发产品是一种“新出现的风险因素”,并同意这种危险至少到目前为止已经得到了数据的证实。其他风险因素仍然不清楚或只是部分了解。作为另一个例子,Giaquinto引用了最近的研究报告,报告称新移民的亚洲和太平洋岛民妇女的乳腺癌发病率高于美国出生的亚太裔妇女。“虽然这种风险增加的确切原因尚不清楚,但这些移民模式也可能导致年轻的亚太裔女性患病人数急剧增加。”澄清可以提高或降低乳腺癌风险的因素可以为更多旨在改变可改变的风险因素和加强监测的推广工作打开大门。托里奥拉博士同意,有针对性的筛查对有家族史或已知危险因素的年轻女性可能有益。然而,许多癌症患者并没有明显的危险因素,这意味着该领域在如何应对日益增长的危险方面还有很多需要学习的地方。
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引用次数: 0
Current landscape and emerging opportunities for using telecytology for rapid on-site assessment in cytopathology 在细胞病理学中使用远程细胞学进行快速现场评估的现状和新机会
IF 3.2 3区 医学 Q3 ONCOLOGY Pub Date : 2025-06-16 DOI: 10.1002/cncy.70027
Savitri Krishnamurthy MD

In recent years, cytopathology practices increasingly are considering the adoption of digital modalities to support remote rapid on-site evaluation (ROSE) of fine-needle aspiration biopsies. Currently, various digital options are available, each of which has unique advantages and limitations. This review covers all relevant aspects of telecytology for ROSE, including digital pathology options, operators, validation, quality assurance, reimbursement, and recommendations from professional organizations. The evolving landscape of telecytology for ROSE, including the development of devices for standardized specimen preparation and staining, next-generation digital microscopy techniques, and deep-learning–based artificial intelligence tools as decision-support aids for the interpretation of digital images, also is outlined.

近年来,细胞病理学实践越来越多地考虑采用数字模式来支持细针穿刺活检的远程快速现场评估(ROSE)。目前,各种数字选项可供选择,每种选项都有其独特的优点和局限性。这篇综述涵盖了ROSE远程学的所有相关方面,包括数字病理选择、操作人员、验证、质量保证、报销和专业组织的建议。还概述了ROSE远程学的发展前景,包括标准化标本制备和染色设备的开发,下一代数字显微镜技术,以及作为数字图像解释决策支持辅助工具的基于深度学习的人工智能工具。
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引用次数: 0
The hidden costs of clinical trials 临床试验的隐性成本
IF 3.2 3区 医学 Q3 ONCOLOGY Pub Date : 2025-06-03 DOI: 10.1002/cncy.70021
Bryn Nelson PhD, William Faquin MD, PhD
<p>Amid the intense controversy over drastic cuts to the National Institutes of Health (NIH) and its workforce, a hotly contested cap on the NIH’s reimbursement of indirect costs for facilities and administrative expenses is focusing new attention on the financial burden of the institutions and trial participants that make clinical research possible.</p><p>In 2023, the NIH distributed more than $35 billion in grants to more than 2500 universities and institutions in all 50 states, Washington, DC, and Puerto Rico. That amount included approximately $26 billion to researchers for the direct costs of conducting their work and an additional $9 billion to cover indirect costs, such as maintenance, utilities, rent, personnel, shared facilities, and other necessary expenses borne by the research institutions. As the Association of American Cancer Institutes (AACI) has phrased it, “indirect costs are what ‘keep the lights on’ at many of our nation’s premier research facilities.”</p><p>Each institution negotiates its percentage rate for indirect cost reimbursements with the NIH based on factors such as the local rental market and other overhead expenses; the rates generally vary from 30% to 70%. In February 2025, however, the Trump administration announced a new formula capping all reimbursements at 15%, regardless of location. Among the many research organizations decrying the move, the AACI charged that the cut “would be devastating for the patients our cancer centers serve and would stifle progress against cancer.”<span><sup>1</sup></span></p><p>The Trump administration has cast the controversial rule as a cost-conscious move that will save the NIH an estimated $4 billion annually. As a rule of thumb, though, economists have suggested that every $1 spent by the institutes yields roughly $2.50 in economic activity. The cuts, in other words, could wipe out $10 billion in economic activity, resulting in a $6 billion net loss.</p><p>Research administrators such as Prakash Nagarkatti, PhD, a professor of pathology, microbiology, and immunology at the University of South Carolina, say that their indirect cost reimbursements are closely tracked and monitored. “It’s not like it just goes into a bucket and disappears,” he says. In a perspective piece in <i>The Conversation</i>, he and his wife, Mitzi Nagarkatti, PhD, also a professor of pathology, microbiology, and immunology at the university, further assert that the funding cuts will hit hardest in red states, rural areas, and underserved communities.<span><sup>2</sup></span> To explain why, they point to a huge geographic disparity in which 27 states receive 94% of all NIH funding. That leaves the remaining 6% of funds to be divided among 23 states—including the 18 least populous ones—and Puerto Rico.</p><p>Dr Prakash Nagarkatti says that more rural states with smaller economies and a relative lack of investment, infrastructure, medical centers, and research universities can struggle to be competitive in NIH
在围绕大幅削减美国国立卫生研究院(NIH)及其员工的激烈争论中,围绕NIH对设备和行政费用间接成本的补偿上限的激烈争论,使人们重新关注使临床研究成为可能的机构和试验参与者的财务负担。2023年,NIH向全美50个州、华盛顿特区和波多黎各的2500多所大学和机构发放了超过350亿美元的赠款。其中约260亿美元用于研究人员开展工作的直接费用,另外90亿美元用于支付间接费用,如维修、公用事业、租金、人员、共用设施和由研究机构承担的其他必要费用。正如美国癌症研究所协会(AACI)所说,“间接成本是我们国家许多一流研究机构‘维持运转’的基础。”每个机构根据当地租赁市场和其他管理费用等因素与NIH协商间接成本报销的百分比;费率一般从30%到70%不等。然而,在2025年2月,特朗普政府宣布了一项新的方案,将所有报销限制在15%,无论地点如何。在众多谴责这一举动的研究机构中,AACI指责说,削减“对我们癌症中心服务的患者来说将是毁灭性的,并将扼杀癌症防治的进展。”特朗普政府将这一有争议的规定视为一项成本意识强的举措,预计每年将为美国国立卫生研究院节省40亿美元。不过,根据经验,经济学家认为,这些机构每花费1美元,就会产生大约2.5美元的经济活动。换句话说,这些削减可能会使100亿美元的经济活动化为乌有,导致60亿美元的净损失。南卡罗来纳大学病理学、微生物学和免疫学教授Prakash Nagarkatti博士等研究管理人员说,他们的间接费用报销受到了密切跟踪和监控。他说:“这并不是说它就这样被放进桶里就消失了。”在The Conversation的一篇观点文章中,他和他的妻子,同时也是该大学病理学、微生物学和免疫学教授的Mitzi Nagarkatti博士进一步断言,资金削减将在红色州、农村地区和服务不足的社区受到最严重的打击为了解释原因,他们指出了巨大的地理差异,27个州获得了NIH全部资金的94%。剩下的6%的资金将分配给23个州(包括18个人口最少的州)和波多黎各。Prakash Nagarkatti博士说,经济规模较小、投资、基础设施、医疗中心和研究型大学相对缺乏的农村邦在NIH拨款申请中可能难以具有竞争力。1993年,一项由国会支持的名为“机构发展奖”(IDeA)的项目开始拨出略低于NIH年度预算1%的资金用于资助这些州,通过发展和扩大研究基础设施以及招聘新教师来提高这些州的竞争力。南卡罗来纳大学的Nagarkatti博士指出,他领导的卓越生物医学研究中心是IDeA资助下投资的一个非常成功的例子。即便如此,IDeA每年4.3亿美元的支出仍未能帮助资源不足的州与其他州持平。在2024年的一份政策文件中,Prakash博士和Mitzi Nagarkatti以及他们的两位同事写道,按人均计算,非IDeA州从NIH获得了120美元,而IDeA州只获得了45.3美元。因此,后者也高度依赖间接成本报销,Prakash Nagarkatti博士说,这至少帮助他们竞争资金,以解决高优先级的地区需求。传统上,美国国立卫生研究院以更高的经常性费率奖励那些升级研究基础设施的机构。他说:“基本上,钱能赚更多的钱。”另一方面,缺乏对陈旧设施的关注可能会降低利率。Nagarkatti博士说,大幅削减NIH的间接成本补偿对这两个群体的州都有害。对于那些投资了基础设施、间接成本较高的机构来说,降至15%意味着更大的损失——从本质上讲,这是对它们加大投资升级设施的惩罚。Prakash Nagarkatti博士认为,对于诸如南卡罗来纳这样的IDeA州来说,削减进一步损害了它们的研究能力和获得未来资助的能力。南卡罗来纳大学目前的报销率为49%。 他估计,降至15%可能会使该大学损失大约1700万至2000万美元,这还不包括因与疫苗或Covid-19研究或与多样性、公平和包容倡议有关而被取消的拨款。“我们将会损失很多钱,”他说。美国癌症协会(ACS)最近将自己的间接费用报销率从20%降低到10% (ACS出版《癌症细胞病理学》)。道格拉斯·赫斯特博士是美国癌症学会的生物化学和免疫学科学主任,他承认,关于正确的比率以及是否应该重新讨论谈判过程,有一场很好的辩论需要进行。“质疑总是好的,”他说。其他研究表明,研究参与者在交通、住宿、食品和儿童保育等必需品上也承担了大量间接成本。根据现有的联邦法规,包括禁止对医疗补助或医疗保险受益人进行引诱的反回扣法规,大多数报销都是不允许的。2025年2月,ACS行动网络和其他20个癌症组织写了一封信,要求监察长卫生与人类服务办公室建立一个监管的“安全港”,允许针对癌症或其他危及生命的疾病或病症的临床试验参与者获得额外费用的补偿。这封信指出,这样的补偿可以改善临床试验的种族、民族和社会经济多样性,这些临床试验一直在努力招募经常承受不成比例疾病负担的患者。而这封信则是由阿拉巴马大学伯明翰分校普通内科和人口科学助理教授、医学博士考特尼·威廉姆斯(Courtney Williams)最近领导的一项研究提供的。她基于调查的研究发现,几乎一半参加癌症临床试验的受访者因参与而面临经济困难这种困难使一半以上的受访者不太愿意参加未来的试验。以前接受过经济和社会支持的患者的小样本量可能限制了研究的普遍性。威廉姆斯博士认为,即便如此,研究结果指出了一个很大程度上尚未解决的问题,值得更多的关注和研究。她说,为了补偿参与者的额外成本,“我们认为每月1000美元不是不可能的。”两项悬而未决的联邦立法将允许试验发起人在财政上支持参与者,以减轻他们的困难,提高应计和保留率。当然,联邦政策的任何变化都会留下一个悬而未决的问题,即谁将提供额外的资金来偿还临床试验参与者的费用。或许,一个更大的问题是,美国是否会继续投资于生物医学中心的能力,以开展改善患者护理所需的研究。对于像Prakash Nagarkatti博士这样的研究人员来说,这意味着不能让间接成本从裂缝中溜走。他说:“我认为我们需要确保公众明白,间接成本不仅有助于支持资助的拨款,而且有助于为未来的资助创造机会,并有助于吸引人才到我们的IDeA州。”他担心,资金削减可能会加剧人才流失,让像他这样的州进一步落后。■
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引用次数: 0
“Other” high-risk HPV: Challenges in anal cancer screening “其他”高危HPV:肛门癌筛查的挑战
IF 3.2 3区 医学 Q3 ONCOLOGY Pub Date : 2025-05-29 DOI: 10.1002/cncy.70025
Margaret L. Compton MD
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引用次数: 0
The diagnostic challenges of medullary thyroid carcinoma: A practical guide for cytopathologists 甲状腺髓样癌的诊断挑战:细胞病理学家的实用指南
IF 3.2 3区 医学 Q3 ONCOLOGY Pub Date : 2025-05-27 DOI: 10.1002/cncy.70023
Marc P. Pusztaszeri MD, Zahra Maleki MD

Medullary thyroid carcinoma (MTC) is a rare but potentially aggressive neuroendocrine tumor arising from the thyroid C cells (parafollicular cells) that produce calcitonin, representing 1%–3% of thyroid malignancies but contributing to up to 15% of thyroid cancer-related deaths. Early detection is critical for improving survival and outcomes because its tumor origin, treatment, and prognosis differ completely from papillary thyroid carcinoma. However, the low incidence of MTC and its variable cytomorphology can pose significant diagnostic challenges for cytopathologists. Referred to as the great mimicker, MTC can resemble various primary and metastatic tumors, complicating its identification, particularly in fine-needle aspiration (FNA) biopsies. Reported FNA sensitivity for a specific MTC diagnosis varies widely from 12.5% to 88.2%, with a 2014 meta-analysis estimating an overall sensitivity of 56.5% when including suspicious lesions. False-negative FNA results, often caused by misinterpretation of cytologic features or inadequate specimen quality, can lead to delayed or suboptimal treatment. Pathologists must be familiar with MTC's diverse cytopathologic presentation and maintain a low threshold for additional diagnostic tests to ensure an accurate preoperative diagnosis. This review article provides practical guidance on diagnosing MTC, emphasizing cytologic features, ancillary studies, mimickers, and common diagnostic pitfalls, serving as a valuable resource for cytopathologists, general pathologists, and trainees to improve diagnostic accuracy and patient care.

甲状腺髓样癌(MTC)是一种罕见但具有潜在侵袭性的神经内分泌肿瘤,由产生降钙素的甲状腺C细胞(滤泡旁细胞)引起,占甲状腺恶性肿瘤的1%-3%,但导致高达15%的甲状腺癌相关死亡。早期发现对提高生存率和预后至关重要,因为其肿瘤起源、治疗和预后与甲状腺乳头状癌完全不同。然而,MTC的低发病率和其多变的细胞形态给细胞病理学家带来了重大的诊断挑战。MTC被称为“伟大的模仿者”,它可以与各种原发和转移性肿瘤相似,这使其鉴定变得复杂,特别是在细针穿刺(FNA)活检中。报道的FNA对特定MTC诊断的敏感性从12.5%到88.2%不等,2014年的荟萃分析估计,当包括可疑病变时,总体敏感性为56.5%。假阴性的FNA结果,通常是由细胞学特征的误解或标本质量不足引起的,可能导致延迟或不理想的治疗。病理学家必须熟悉MTC的不同细胞病理学表现,并保持低阈值的额外诊断测试,以确保准确的术前诊断。这篇综述文章提供了诊断MTC的实用指南,强调细胞学特征,辅助研究,模拟物和常见的诊断陷阱,为细胞病理学家,普通病理学家和实习生提供了宝贵的资源,以提高诊断准确性和患者护理。
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引用次数: 0
Implementing 100% quality control in a cervical cytology workflow using whole slide images and artificial intelligence provided by the Techcyte SureView™ System 使用Techcyte SureView™系统提供的整个幻灯片图像和人工智能,在宫颈细胞学工作流程中实施100%的质量控制
IF 3.2 3区 医学 Q3 ONCOLOGY Pub Date : 2025-05-19 DOI: 10.1002/cncy.70019
Maria del Mar Rivera Rolon MD, FCAP, Erik Gustafson PhD, Riley Cole BA, MA, Jaylene Matos CT (ASCP), CM, Kellie Hicken CT (ASCP), BS, Jacob Hicks BS, MBA, Brian Cahoon BS, MBA, Mariano de Socarraz, Juan Carlos Santa-Rosario MD, FCAP, FASCP

Background

Recent advancements in digital pathology have extended into cytopathology. Laboratories screening cervical cytology specimens now choose between limited imaging options and traditional manual microscopy. The Techcyte SureView™ Cervical Cytology System, designed for digital cytopathology, was validated at CorePlus, a pathology laboratory in Puerto Rico, and adopted as a 100% quality control (QC) tool.

Methods

The validation study included 1442 whole slide images (WSIs) from 1273 ThinPrep® and 169 SurePath™ cervical cytology slides, digitized with the 3DHISTECH Panoramic 1000 DX scanner using dry and water immersion scanning profiles. These WSIs were processed by the Techcyte SureView™ system, with a board-certified cytopathologist reviewing artificial intelligence (AI)-identified objects of interest and comparing them to traditional light microscopy results.

Results

Techcyte SureView™ with the water immersion scanning profile outperformed both the dry scanning profile and light microscopy in detecting squamous and glandular abnormalities. It achieved 97% accuracy, 82% sensitivity, 99% specificity, 98% negative predictive value, and 86% positive predictive value. Additionally, the review time was rapid. The system has been operational for several months, enhancing accuracy and workflow efficiency.

Conclusions

This study demonstrates that digital cytopathology, particularly through the Techcyte SureView™ system, can improve laboratory workflow and performance. Successful validation led CorePlus to integrate the AI algorithm into their workflow as a 100% QC review tool, resulting in improved accuracy, benefiting both laboratory professionals and patients.

最近数字病理学的进展已经扩展到细胞病理学。筛选宫颈细胞学标本的实验室现在在有限的成像选项和传统的人工显微镜之间进行选择。专为数字细胞病理学设计的Techcyte SureView™宫颈细胞学系统在波多黎各的CorePlus病理实验室进行了验证,并被采用为100%质量控制(QC)工具。方法验证研究包括1442张全片图像(wsi),来自1273张ThinPrep®和169张SurePath™宫颈细胞学切片,使用3DHISTECH全景1000 DX扫描仪使用干式和水浸式扫描剖面进行数字化。这些wsi由Techcyte SureView™系统处理,由委员会认证的细胞病理学家审查人工智能(AI)识别的感兴趣对象,并将其与传统光学显微镜结果进行比较。结果采用水浸扫描技术的Techcyte SureView™在检测鳞状和腺体异常方面优于干燥扫描和光学显微镜。准确率97%,灵敏度82%,特异性99%,阴性预测值98%,阳性预测值86%。另外,复习时间也很快。该系统已经运行了几个月,提高了准确性和工作效率。本研究表明,数字细胞病理学,特别是通过Techcyte SureView™系统,可以改善实验室工作流程和性能。成功的验证使CorePlus将人工智能算法集成到他们的工作流程中,作为100%的QC审查工具,从而提高了准确性,使实验室专业人员和患者都受益。
{"title":"Implementing 100% quality control in a cervical cytology workflow using whole slide images and artificial intelligence provided by the Techcyte SureView™ System","authors":"Maria del Mar Rivera Rolon MD, FCAP,&nbsp;Erik Gustafson PhD,&nbsp;Riley Cole BA, MA,&nbsp;Jaylene Matos CT (ASCP), CM,&nbsp;Kellie Hicken CT (ASCP), BS,&nbsp;Jacob Hicks BS, MBA,&nbsp;Brian Cahoon BS, MBA,&nbsp;Mariano de Socarraz,&nbsp;Juan Carlos Santa-Rosario MD, FCAP, FASCP","doi":"10.1002/cncy.70019","DOIUrl":"10.1002/cncy.70019","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Recent advancements in digital pathology have extended into cytopathology. Laboratories screening cervical cytology specimens now choose between limited imaging options and traditional manual microscopy. The Techcyte SureView™ Cervical Cytology System, designed for digital cytopathology, was validated at CorePlus, a pathology laboratory in Puerto Rico, and adopted as a 100% quality control (QC) tool.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The validation study included 1442 whole slide images (WSIs) from 1273 ThinPrep® and 169 SurePath™ cervical cytology slides, digitized with the 3DHISTECH Panoramic 1000 DX scanner using dry and water immersion scanning profiles. These WSIs were processed by the Techcyte SureView™ system, with a board-certified cytopathologist reviewing artificial intelligence (AI)-identified objects of interest and comparing them to traditional light microscopy results.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Techcyte SureView™ with the water immersion scanning profile outperformed both the dry scanning profile and light microscopy in detecting squamous and glandular abnormalities. It achieved 97% accuracy, 82% sensitivity, 99% specificity, 98% negative predictive value, and 86% positive predictive value. Additionally, the review time was rapid. The system has been operational for several months, enhancing accuracy and workflow efficiency.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This study demonstrates that digital cytopathology, particularly through the Techcyte SureView™ system, can improve laboratory workflow and performance. Successful validation led CorePlus to integrate the AI algorithm into their workflow as a 100% QC review tool, resulting in improved accuracy, benefiting both laboratory professionals and patients.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9410,"journal":{"name":"Cancer Cytopathology","volume":"133 6","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cncy.70019","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluating the diagnostic accuracy of imprint and scrape cytology for intraoperative risk stratification of ovarian tumors: A systematic review and meta-analysis 评估印迹和刮痕细胞学对卵巢肿瘤术中风险分层的诊断准确性:一项系统回顾和荟萃分析
IF 3.2 3区 医学 Q3 ONCOLOGY Pub Date : 2025-05-19 DOI: 10.1002/cncy.70024
Mishu Mangla MBBS, MS, PDCC, Seetu Palo MBBS, MD, Anusha Devalla MBBS, MS, DNB, Poojitha Kalyani Kanikaram MBBS, MD

Background

Accurate intraoperative assessment of ovarian tumors is crucial for guiding surgical management. The objective of this systematic review and meta-analysis was to evaluate the diagnostic accuracy of imprint and scrape cytology for intraoperative risk stratification of ovarian tumors.

Methods

A comprehensive literature search was conducted across multiple databases to identify studies that assessed the sensitivity, specificity, positive predictive value, and negative predictive value of imprint and scrape cytology in distinguishing benign and malignant ovarian tumors. Data were pooled using a bivariate random-effects model. The methodological quality of included studies was assessed using the quality assessment of diagnostic accuracy studies 2 tool.

Results

In total, 34 studies comprising 3318 ovarian tumors were included in the current review. Analysis indicated that the pooled sensitivity of imprint cytology was 89%, whereas the pooled specificity was 92%. The positive and negative likelihood ratios, calculated using a random-effects model, were 8.47 (95% confidence interval [CI], 5.27–13.61) and 0.16 (95% CI, 0.12–0.21), respectively. The pooled diagnostic odds ratio was 63.42 (95% CI, 37.5–107.27). For scrape cytology, the pooled sensitivity and specificity were 89% and 97%, respectively. The positive and negative likelihood ratios were 21.05 (95% CI, 12.36–35.84) and 0.14 (95% CI, 0.09–0.22), respectively. The pooled diagnostic odds ratio was 180.46 (95% CI, 88.01–370.03). Both techniques demonstrated high diagnostic accuracy, and scrape cytology was particularly effective in detecting malignancies.

Conclusions

Imprint and scrape cytology are valuable intraoperative diagnostic tools for ovarian tumor stratification, offering rapid and reliable results. Their integration into surgical decision making may enhance intraoperative management, particularly in resource-limited settings. Further studies with standardized protocols are needed to refine their clinical utility.

背景准确的术中评估卵巢肿瘤对指导手术治疗至关重要。本系统综述和荟萃分析的目的是评估印迹和刮痕细胞学对卵巢肿瘤术中危险分层的诊断准确性。方法对多个数据库进行综合文献检索,找出印迹细胞学和刮痕细胞学鉴别卵巢良恶性肿瘤的敏感性、特异性、阳性预测值和阴性预测值的研究。数据采用双变量随机效应模型汇总。使用诊断准确性研究2的质量评估工具对纳入研究的方法学质量进行评估。结果本综述共纳入34项研究,包括3318例卵巢肿瘤。分析表明,印迹细胞学的综合敏感性为89%,而综合特异性为92%。使用随机效应模型计算的正似然比和负似然比分别为8.47(95%可信区间[CI], 5.27-13.61)和0.16 (95% CI, 0.12-0.21)。合并诊断优势比为63.42 (95% CI, 37.5-107.27)。对于刮伤细胞学,合并敏感性和特异性分别为89%和97%。阳性和阴性似然比分别为21.05 (95% CI, 12.36-35.84)和0.14 (95% CI, 0.09-0.22)。合并诊断优势比为180.46 (95% CI, 88.01-370.03)。这两种技术都显示出很高的诊断准确性,刮片细胞学在检测恶性肿瘤方面特别有效。结论印迹细胞学和刮片细胞学是卵巢肿瘤分层诊断的重要工具,诊断结果快速可靠。将它们整合到手术决策中可以加强术中管理,特别是在资源有限的情况下。需要进一步研究标准化方案,以完善其临床应用。
{"title":"Evaluating the diagnostic accuracy of imprint and scrape cytology for intraoperative risk stratification of ovarian tumors: A systematic review and meta-analysis","authors":"Mishu Mangla MBBS, MS, PDCC,&nbsp;Seetu Palo MBBS, MD,&nbsp;Anusha Devalla MBBS, MS, DNB,&nbsp;Poojitha Kalyani Kanikaram MBBS, MD","doi":"10.1002/cncy.70024","DOIUrl":"10.1002/cncy.70024","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Accurate intraoperative assessment of ovarian tumors is crucial for guiding surgical management. The objective of this systematic review and meta-analysis was to evaluate the diagnostic accuracy of imprint and scrape cytology for intraoperative risk stratification of ovarian tumors.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A comprehensive literature search was conducted across multiple databases to identify studies that assessed the sensitivity, specificity, positive predictive value, and negative predictive value of imprint and scrape cytology in distinguishing benign and malignant ovarian tumors. Data were pooled using a bivariate random-effects model. The methodological quality of included studies was assessed using the quality assessment of diagnostic accuracy studies 2 tool.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In total, 34 studies comprising 3318 ovarian tumors were included in the current review. Analysis indicated that the pooled sensitivity of imprint cytology was 89%, whereas the pooled specificity was 92%. The positive and negative likelihood ratios, calculated using a random-effects model, were 8.47 (95% confidence interval [CI], 5.27–13.61) and 0.16 (95% CI, 0.12–0.21), respectively. The pooled diagnostic odds ratio was 63.42 (95% CI, 37.5–107.27). For scrape cytology, the pooled sensitivity and specificity were 89% and 97%, respectively. The positive and negative likelihood ratios were 21.05 (95% CI, 12.36–35.84) and 0.14 (95% CI, 0.09–0.22), respectively. The pooled diagnostic odds ratio was 180.46 (95% CI, 88.01–370.03). Both techniques demonstrated high diagnostic accuracy, and scrape cytology was particularly effective in detecting malignancies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Imprint and scrape cytology are valuable intraoperative diagnostic tools for ovarian tumor stratification, offering rapid and reliable results. Their integration into surgical decision making may enhance intraoperative management, particularly in resource-limited settings. Further studies with standardized protocols are needed to refine their clinical utility.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9410,"journal":{"name":"Cancer Cytopathology","volume":"133 6","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cncy.70024","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085350","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of race, ethnicity, and human immunodeficiency virus status on anal high-risk HPV subtypes: Preliminary insights from a diverse urban population 种族、民族和人类免疫缺陷病毒状态对肛门高危HPV亚型的影响:来自不同城市人口的初步见解
IF 3.2 3区 医学 Q3 ONCOLOGY Pub Date : 2025-05-06 DOI: 10.1002/cncy.70020
Nikka Khorsandi MD, MPH, Poonam Vohra MD, Peyman Samghabadi MD, Carlo De La Sancha Verduzco MD, Dominic Lung Ct(Ascp), Freddy Chou MS, Steven R. Long MD

Introduction

Racial differences have been identified in the distribution of cervical high-risk human papillomavirus (hrHPV) subtypes; however, there is limited understanding of hrHPV subtypes in anal specimens based on patient race/ethnicity. This knowledge gap limits possible vaccination and/or treatment efforts and may not provide optimal coverage in diverse populations.

Materials and Methods

This preliminary study evaluates anal hrHPV subtype distribution and cytological outcomes in a diverse population accessing care at a large, urban, publicly funded hospital over a 2-year period. The primary objectives were to analyze anal hrHPV subtypes and associated cytologic diagnoses, focusing on disparities among demographic groups, including racial and ethnic diversity, and among individuals living with human immunodeficiency virus (HIV).

Results

Ninety-two patients were identified with a predominance of male (87%) and gay-identifying (50%) individuals and a significant representation from Hispanic/Latinx (36%) and White (36%) backgrounds. A majority (88%) were living with HIV, and only a small fraction (7%) had received HPV vaccination. The most common hrHPV subtypes identified were non-16 and 18 hrHPV subtypes (46%). No significant differences were identified in distribution of HPV subtypes among different races/ethnicities or between sexual and gender minorities and heterosexual, cisgender-identifying individuals. However, individuals with HIV were more likely to have atypical cytologic diagnoses and non-16/18 HPV subtypes.

Conclusions

The findings underscore the prevalence of non-16/18 hrHPV subtypes in a racially and ethnically diverse urban population, particularly among individuals living with HIV. The study highlights the need for expanded HPV subtype surveillance and vaccine development to ensure equitable prevention strategies across diverse populations.

宫颈高危人乳头瘤病毒(hrHPV)亚型的分布已经确定了种族差异;然而,基于患者种族/民族对肛门标本中hrHPV亚型的了解有限。这种知识差距限制了可能的疫苗接种和/或治疗工作,并且可能无法在不同人群中提供最佳覆盖率。材料和方法本初步研究评估了在大型城市公立医院就诊的不同人群的肛门hrHPV亚型分布和细胞学结果,为期2年。主要目的是分析肛门hrHPV亚型和相关细胞学诊断,重点关注人口统计学群体之间的差异,包括种族和民族多样性,以及人类免疫缺陷病毒(HIV)感染者之间的差异。结果92例患者以男性(87%)和同性恋(50%)为主,西班牙裔/拉丁裔(36%)和白人(36%)背景占显著比例。大多数人(88%)感染了艾滋病毒,只有一小部分人(7%)接种了HPV疫苗。最常见的hrHPV亚型是非16型和18型(46%)。HPV亚型在不同种族/民族之间或性少数和性别少数群体与异性恋、顺性别认同个体之间的分布未发现显著差异。然而,艾滋病毒感染者更有可能有非典型细胞学诊断和非16/18 HPV亚型。结论:研究结果强调了非16/18 hrHPV亚型在不同种族和民族的城市人群中的流行,特别是在艾滋病毒感染者中。该研究强调需要扩大HPV亚型监测和疫苗开发,以确保在不同人群中采取公平的预防策略。
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引用次数: 0
Does artificial intelligence redefine nuclear-to-cytoplasmic ratio threshold for diagnosing high-grade urothelial carcinoma? 人工智能是否重新定义了诊断高级别尿路上皮癌的核质比阈值?
IF 3.2 3区 医学 Q3 ONCOLOGY Pub Date : 2025-05-03 DOI: 10.1002/cncy.70017
Wei-Lei Yang PhD, Barbara A. Crothers DO, Tien-Jen Liu MD, Shih-Wen Hsu MS, Cheng-Hung Yeh MS, Yi-Siou Liu MS, Guowei Shao MS, Ming-Yu Lin PhD, Tang-Yi Tsao MD, Min-Che Tung MD, Pei-Yi Chu MD, Jen-Fan Hang MD, FIAC

Background

The Paris System (TPS) introduced standardized nuclear-to-cytoplasmic (N/C) ratio thresholds for urine cytology to improve high-grade urothelial carcinoma (HGUC) detection, but these criteria remain subjective. This study used AIxURO, an artificial intelligence-based model, to measure N/C ratio and nuclear area to identify abnormal cells in whole slide images (WSIs).

Methods

A total of 106 urine cytology slides from 46 lower urinary tract (LUT) and 60 upper urinary tract (UUT) cancer cases, diagnosed as atypical urothelial cell (15.1%), suspicious for high-grade urothelial carcinoma (SHGUC) (23.6%), and HGUC (61.3%), with biopsy-confirmed HGUC or carcinoma in situ (CIS), were digitized and analyzed by AIxURO. The model quantified suspicious and atypical cells, N/C ratios, and nuclear areas, with statistical differences assessed using Kruskal–Wallis tests.

Results

AIxURO identified fewer suspicious cells than atypical cells (20.5 vs. 242.0, p < .001). Suspicious cells had higher N/C ratios (0.66 vs. 0.58, p < .001) and larger nuclear areas (102.3 vs. 85.7 µm2, p < .001). Although N/C ratios did not differ significantly between UUT and LUT cases, nuclear areas varied among abnormal cells (CIS: 101.5 µm2; HGUC: 83.5 µm2). In HGUC cytology cases, the CIS category had larger nuclear areas than HGUC for both suspicious (116.3 vs. 100.4 µm2) and atypical cells (101.5 vs. 82.2 µm2).

Conclusions

AIxURO provides objective quantification of N/C ratios and nuclear areas, refining TPS criteria for distinguishing suspicious from atypical cells. A lower N/C ratio cutoff (0.66) for SHGUC/HGUC may be more appropriate than the TPS threshold (>0.7). Findings support using consistent N/C ratio criteria across UUT and LUT cases.

巴黎系统(TPS)引入了标准化的尿细胞学核/细胞质(N/C)比值阈值,以提高高级别尿路上皮癌(HGUC)的检测,但这些标准仍然是主观的。本研究采用基于人工智能的AIxURO模型,测量N/C比率和核面积,以识别全片图像(WSIs)中的异常细胞。方法对诊断为非典型尿路上皮细胞(15.1%)、怀疑为高级别尿路上皮癌(SHGUC)(23.6%)、怀疑为HGUC(61.3%)、活检证实为HGUC或原位癌(CIS)的46例下尿路癌(LUT)和60例上尿路癌(UUT)患者的106张尿细胞学切片进行数字化分析。该模型量化了可疑和非典型细胞、N/C比率和核面积,并使用Kruskal-Wallis试验评估了统计差异。结果AIxURO鉴定出的可疑细胞少于非典型细胞(20.5 vs. 242.0, p <;措施)。可疑细胞的N/C比值较高(0.66 vs. 0.58, p <;.001)和更大的核区域(102.3 vs. 85.7µm2, p <;措施)。尽管在UUT和LUT病例中N/C比率没有显著差异,但异常细胞的核面积存在差异(CIS: 101.5µm2;HGUC: 83.5µm2)。在HGUC细胞学病例中,CIS类别的可疑细胞(116.3 vs 100.4µm2)和非典型细胞(101.5 vs 82.2µm2)的核面积都比HGUC大。结论AIxURO提供了客观定量的N/C比和核面积,完善了TPS标准,用于区分可疑细胞和非典型细胞。SHGUC/HGUC较低的N/C比值临界值(0.66)可能比TPS阈值(>0.7)更合适。研究结果支持在UUT和LUT病例中使用一致的N/C比率标准。
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Cancer Cytopathology
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