Clinical trial NCT05485077: A Prospective Cohort Study on Colorectal Cancer Screening in Community Population
Official title: Colorectal Cancer Screening Cohort Study in Shougang Community Population Based on Polygene Methylation Detection Technology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Keywords: ctDNA methylation
Community population screening
Lead sponsor: Singlera Genomics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Peking University Shougang Hospital
First posted: 2022-08-03
Enrollment: 18000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18000 samples from Shougang community

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Sensitivity and specificity of polygene methylation detection in colorectal cancer
timeFrame: assessed up to 72 months
measure: Negative predictive value and positive predictive value of polygene methylation in colorectal cancer
timeFrame: assessed up to 72 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
Study officials:
affiliation: Singlera Genomics Inc.
name: Rui Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 gastrointestinal epithelial neoplasia. Gut. 2000 Aug;47(2):251-5. doi: 10.1136/gut.47.2.251.
citation: 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.
citation: 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: 10.1053/j.gastro.2021.08.054. Epub 2021 Sep 4. No abstract available.