Colorectal cAncer and CrohN's DIsease study (CANDID): An international multicentre retrospective audit

IF 2.7 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Colorectal Disease Pub Date : 2025-01-26 DOI:10.1111/codi.70005

Zoe Garoufalia, Sameh Hany Emile, Justin Dourado, Marylise Boutros, Richard Brady, Valerio Celentano, Justin Davies, Phillip R. Fleshner, Rachel Gefen, Stefan D. Holubar, Nir Horesh, Alaa El-Hussuna, Deborah Keller, Amy Lightner, Gianluca Pellino, Sherief Shawki, Spyros Siakavellas, Antonino Spinelli, Janindra Warusavitarne, Steven D. Wexner

{"title":"Colorectal cAncer and CrohN's DIsease study (CANDID): An international multicentre retrospective audit","authors":"Zoe Garoufalia, Sameh Hany Emile, Justin Dourado, Marylise Boutros, Richard Brady, Valerio Celentano, Justin Davies, Phillip R. Fleshner, Rachel Gefen, Stefan D. Holubar, Nir Horesh, Alaa El-Hussuna, Deborah Keller, Amy Lightner, Gianluca Pellino, Sherief Shawki, Spyros Siakavellas, Antonino Spinelli, Janindra Warusavitarne, Steven D. Wexner","doi":"10.1111/codi.70005","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Inflammatory bowel disease (IBD) affects more than 10 million people worldwide. Men and women are equally affected by Crohn's disease (CD). It has been shown that patients with CD are at an increased risk of a colorectal cancer (CRC) diagnosis and CRC-related mortality. During the last two decades, biological therapies have revolutionized the treatment of CD. There are no current studies investigating the prevalence of CRC in patients with CD in the era of biological therapy and the possible features of patients with CD who are at high risk of developing CRC.</p>\n </section>\n \n <section>\n \n <h3> Aim</h3>\n \n <p>We aim to assess the prevalence of CRC, risk factors and profile of CRC in patients with CD receiving biological treatment compared with those who are not under biological therapy and the impact of CD-associated colorectal strictures on CRC development. The study hypothesis is that the use of biological therapy in the control of CD activity may decrease the risk of developing CRC.</p>\n </section>\n \n <section>\n \n <h3> Study design and setting</h3>\n \n <p>An international, retrospective, snapshot of the prevalence of CRC in patients with CD, reported according to the SPIRIT guidelines. The study will involve centres that hold regular IBD multidisciplinary team meetings and have both IBD colorectal surgeons and gastroenterologists. Each participating centre will provide a local consultant lead and a local trainee lead. Data will be collected within a 2-year recruitment period (January 2017–January 2019).</p>\n </section>\n \n <section>\n \n <h3> Study population</h3>\n \n <p>Adult patients who presented with CD during the study period. Patients with an incidental diagnosis of CD during evaluation for CRC will be excluded.</p>\n </section>\n \n <section>\n \n <h3> Statistical plan</h3>\n \n <p>Baseline patient characteristics will be summarized using the appropriate descriptive statistics. Univariable, multivariable and Cox regression models will be used to identify factors significantly associated with CRC. For noncontinuous variables a comparison between the subgroups will be carried out using the chi-square test corrected by Fisher's exact test if appropriate. A <i>p</i>-value of <0.05 will be considered statistically significant.</p>\n </section>\n \n <section>\n \n <h3> Data storage</h3>\n \n <p>Data will be stored on a secured server, pin-code protected according to the local data management agreement.</p>\n </section>\n </div>","PeriodicalId":10512,"journal":{"name":"Colorectal Disease","volume":"27 2","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2025-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/codi.70005","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Colorectal Disease","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/codi.70005","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Inflammatory bowel disease (IBD) affects more than 10 million people worldwide. Men and women are equally affected by Crohn's disease (CD). It has been shown that patients with CD are at an increased risk of a colorectal cancer (CRC) diagnosis and CRC-related mortality. During the last two decades, biological therapies have revolutionized the treatment of CD. There are no current studies investigating the prevalence of CRC in patients with CD in the era of biological therapy and the possible features of patients with CD who are at high risk of developing CRC.

Aim

We aim to assess the prevalence of CRC, risk factors and profile of CRC in patients with CD receiving biological treatment compared with those who are not under biological therapy and the impact of CD-associated colorectal strictures on CRC development. The study hypothesis is that the use of biological therapy in the control of CD activity may decrease the risk of developing CRC.

Study design and setting

An international, retrospective, snapshot of the prevalence of CRC in patients with CD, reported according to the SPIRIT guidelines. The study will involve centres that hold regular IBD multidisciplinary team meetings and have both IBD colorectal surgeons and gastroenterologists. Each participating centre will provide a local consultant lead and a local trainee lead. Data will be collected within a 2-year recruitment period (January 2017–January 2019).

Study population

Adult patients who presented with CD during the study period. Patients with an incidental diagnosis of CD during evaluation for CRC will be excluded.

Statistical plan

Baseline patient characteristics will be summarized using the appropriate descriptive statistics. Univariable, multivariable and Cox regression models will be used to identify factors significantly associated with CRC. For noncontinuous variables a comparison between the subgroups will be carried out using the chi-square test corrected by Fisher's exact test if appropriate. A p-value of <0.05 will be considered statistically significant.

Data storage

Data will be stored on a secured server, pin-code protected according to the local data management agreement.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

结肠直肠癌和克罗恩病研究（CANDID）：国际多中心回顾性审计

炎症性肠病（IBD）影响全球超过1000万人。克罗恩病（CD）对男性和女性的影响是一样的。已有研究表明，乳糜泻患者患结直肠癌（CRC）的风险和CRC相关死亡率均有所增加。在过去的二十年中，生物治疗彻底改变了CD的治疗。目前还没有研究调查生物治疗时代CD患者CRC的患病率以及CD患者发生CRC的高风险特征。我们的目的是评估接受生物治疗的CD患者与未接受生物治疗的CD患者的CRC患病率、危险因素和CRC概况，以及CD相关结直肠狭窄对CRC发展的影响。该研究的假设是，使用生物疗法来控制CD活性可能会降低发生CRC的风险。研究设计和设置：根据SPIRIT指南，对CD患者CRC患病率进行国际、回顾性、快照调查。该研究将涉及定期举行IBD多学科小组会议的中心，并有IBD结肠直肠外科医生和胃肠病学家。每个参与中心将提供一名当地顾问领导和一名当地培训领导。数据将在2年的招聘期内（2017年1月- 2019年1月）收集。研究人群研究期间出现乳糜泻的成年患者。在CRC评估过程中偶然诊断为CD的患者将被排除在外。统计计划基线患者特征将使用适当的描述性统计进行总结。单变量、多变量和Cox回归模型将用于识别与CRC显著相关的因素。对于不连续变量，子组之间的比较将使用卡方检验进行，如果适当的话，用Fisher精确检验进行修正。p值为<；0.05将被认为具有统计学意义。数据存储数据将存储在安全的服务器上，根据本地数据管理协议进行pin码保护。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Colorectal Disease 医学-胃肠肝病学

CiteScore

6.10

自引率

11.80%

发文量

406

审稿时长

1.5 months

期刊介绍： Diseases of the colon and rectum are common and offer a number of exciting challenges. Clinical, diagnostic and basic science research is expanding rapidly. There is increasing demand from purchasers of health care and patients for clinicians to keep abreast of the latest research and developments, and to translate these into routine practice. Technological advances in diagnosis, surgical technique, new pharmaceuticals, molecular genetics and other basic sciences have transformed many aspects of how these diseases are managed. Such progress will accelerate. Colorectal Disease offers a real benefit to subscribers and authors. It is first and foremost a vehicle for publishing original research relating to the demanding, rapidly expanding field of colorectal diseases. Essential for surgeons, pathologists, oncologists, gastroenterologists and health professionals caring for patients with a disease of the lower GI tract, Colorectal Disease furthers education and inter-professional development by including regular review articles and discussions of current controversies. Note that the journal does not usually accept paediatric surgical papers.