A Prospective Cohort Study on Colorectal Cancer Screening in Community Population

Официальное название

Colorectal Cancer Screening Cohort Study in Shougang Community Population Based on Polygene Methylation Detection Technology

Обзор

This study will validate the real world results of polygene methylation detection in colorectal cancer in a large prospective community cohort. In this study, questionnaire survey and polygene methylation detection technology of colorectal cancer were used as preliminary screening methods, and colonoscopy was used as further validation examination method to screen colorectal cancer and precancerous lesions. The diagnosis and outcome of all lesions were based on colonoscopy and pathological examination.

Подробное описание

1. The informed consent signed by shougang Community will be completed in the baseline period: Colorectal cancer risk factors assessment questionnaire, medical history collection, fecal immunochemical (FIT), carcinoembryonic antigen (CEA) blood test and blood bowel cancer gene methylation detection, for colorectal cancer gene methylation detection results more positive subjects and the result of the negative part of the subjects (n = 500), within 3 months after receiving the results complete colonoscopy. 2. Follow-up at 1, 2, 3, 4, and 5 years after baseline included: ① Central follow-up at 1, 3, and 5 years: history collection, colonoscopy, FIT test, and CEA examination; ② Telephone follow-up at the 2nd and 4th years: medical history was collected; (3) Survival outcome registration was performed in the fifth year; Follow-up history was collected at 1, 2, 3, 4, and 5 years after completion of baseline, and survival outcomes were registered at 5 years. 3. During the follow-up, the subjects were confirmed to be diagnosed with colorectal cancer by evaluation (colorectal cancer was diagnosed by colonoscopy), and the subjects who were treated after polyps or adenomas were found during colonoscopy also reached the study endpoint.

Первичные конечные точки

• Sensitivity and specificity of polygene methylation detection in colorectal cancer [Срок оценки: assessed up to 72 months]
• Negative predictive value and positive predictive value of polygene methylation in colorectal cancer [Срок оценки: assessed up to 72 months]

Критерии участия

Критерии включения

• Chronological age ≥40 years;
• Full capacity for action;
• After enrollment, the participants were able to complete the Colorectal Cancer Risk Factor Assessment Questionnaire and the annual follow-up interviews;
• In the course of the study, the information related to tumor diagnosis in other hospitals can be timely fed back to the researchers;

Критерии исключения

• History of colorectal cancer and other malignant tumors;
• Previous colorectal resection;
• undergoing any cancer-related treatment;
• Patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months;
• Participate in other interventional clinical investigators within 3 months;
• Pregnant or lactating women;
• Have autoimmune disease, hereditary disease, mental illness/disability, etc
• Poor compliance, unable to complete the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Peking University Shougang Hospital — Пекин

Публикации

• Schlemper RJ, Riddell RH, Kato Y, Borchard F, Cooper HS, Dawsey SM, Dixon MF, Fenoglio-Preiser CM, Flejou JF, Geboes K, Hattori T, Hirota T, Itabashi M, Iwafuchi M, Iwashita A, Kim YI, Kirchner T, Klimpfinger M, Koike M, Lauwers GY, Lewin KJ, Oberhuber G, Offner F, Price AB, Rubio CA, Shimizu M, Shimoda T, Sipponen P, Solcia E, Stolte M, Watanabe H, Yamabe H. The Vienna classification of gastroint PMID 10896917
• Guo S, Diep D, Plongthongkum N, Fung HL, Zhang K, Zhang K. Identification of methylation haplotype blocks aids in deconvolution of heterogeneous tissue samples and tumor tissue-of-origin mapping from plasma DNA. Nat Genet. 2017 Apr;49(4):635-642. doi: 10.1038/ng.3805. Epub 2017 Mar 6. PMID 28263317
• Cai G, Cai M, Feng Z, Liu R, Liang L, Zhou P; ColonAiQ Group; Zhu B, Mo S, Wang H, Lan X, Cai S, Xu Y, Wang R, Dai W, Han L, Xiang W, Wang B, Guo W, Zhang L, Zhou C, Luo B, Li Y, Nie Y, Ma C, Su Z. A Multilocus Blood-Based Assay Targeting Circulating Tumor DNA Methylation Enables Early Detection and Early Relapse Prediction of Colorectal Cancer. Gastroenterology. 2021 Dec;161(6):2053-2056.e2. doi: PMID 34487783

Идентификаторы

NCT: NCT05485077 · KYS-2022007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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