Investigating paediatric sarcoma management worldwide: a study protocol

W. Wong, S. Bandyopadhyay, H. Zuberi, M. R. Raza, Abdullahi N Koko, N. Peter, K. Lakhoo
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Abstract

Cancer is the leading cause of non-accidental death among children worldwide. The most common types of paediatric cancers include sarcomas: a group of cancers that are difficult to manage due to their heterogeneity and lack of defining features. We have designed an international multicentre cohort study to assess the management of paediatric sarcomas at tertiary healthcare centres in Nigeria, Pakistan and the UK. The centres will screen patient databases to identify eligible patients under the age of 18 with a clinical or histological diagnosis of sarcoma. Data will be extracted from the patient notes through an anonymized form. Patients will be recruited consecutively into the study from January 2015 to January 2021, with a minimum 12-month follow up period. The primary objectives of the study will be to determine all-cause mortality rates at 30 days, 90 days, 12 months and 3 years. Significant differences in mortality rates between countries will be determined using χ2 analysis or Fisher’s exact test. Univariate and multivariable logistic regression will be used to examine the influence of different factors and patient characteristics on outcomes. At the host centre, this study was deemed to be exempt from ethical committee approval due to the use of anonymized data. At other centres, participating collaborators have gained local approvals in accordance with institutional ethical regulations. Collaborators will present the data to inform decision makers about how sarcoma management may be improved. The results will be submitted for publication in a peer-reviewed journal.
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调查世界范围内的儿童肉瘤管理:一项研究方案
癌症是全世界儿童非意外死亡的主要原因。最常见的儿科癌症类型包括肉瘤:这是一组由于其异质性和缺乏明确特征而难以控制的癌症。我们设计了一项国际多中心队列研究,以评估尼日利亚、巴基斯坦和英国三级医疗中心对儿科肉瘤的管理。这些中心将筛选患者数据库,以确定18岁以下临床或组织学诊断为肉瘤的合格患者。数据将通过匿名表格从患者笔记中提取。患者将从2015年1月至2021年1月连续招募到研究中,随访期至少为12个月。该研究的主要目标是确定30天、90天、12个月和3年的全因死亡率。各国死亡率的显著差异将通过χ2分析或Fisher精确检验来确定。将使用单变量和多变量逻辑回归来检查不同因素和患者特征对结果的影响。在主办中心,由于使用了匿名数据,这项研究被认为不受伦理委员会的批准。在其他中心,参与合作者已根据机构道德法规获得当地批准。合作者将提供数据,告知决策者如何改进肉瘤管理。研究结果将提交同行评审期刊发表。
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