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Trial Title: A Prospective Cohort Study on Colorectal Cancer Screening in Community Population

NCT ID: NCT05485077

Condition: Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms

Conditions: Keywords:
ctDNA methylation
Community population screening

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

Study pop:
18000 samples from Shougang community

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 40 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Peking University Shougang Hospital

Address:
City: Beijing
Zip: 100144
Country: China

Status: Recruiting

Contact:
Last name: Jin Gu, Doctor

Phone: 010-57830127
Email: yuanping_632@163.com

Contact backup:
Last name: Ping Yuan

Phone: 15210919487

Start date: July 9, 2022

Completion date: July 9, 2028

Lead sponsor:
Agency: Singlera Genomics Inc.
Agency class: Industry

Collaborator:
Agency: Peking University Shougang Hospital
Agency class: Other

Source: Singlera Genomics Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05485077

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