NCT05336539

A Community Population Screening Cohort Study Based on Polygene Methylation Detection for Colorectal Cancer in Yangzhou

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80,000 (estimated)
• Sponsor: Singlera Genomics Inc. · Industry
• Sex: All
• Age: 40 Years – 74 Years
• Healthy volunteers: Accepted

Summary

This is a cross-sectional cohort study based on community population jointly developed by Northern Jiangsu People's Hospital and Shanghai Kunyuan Biological Technology Co., LTD. This study will verify the real world results of polygene methylation detection of colorectal cancer in a large prospective cohort of community population, which is expected to enroll 80,000 permanent residents in Yangzhou city. The preliminary design period of the study is 5 years. In this study, questionnaire survey and polygene methylation test of colorectal cancer were used as the primary screening method, and colonoscopy was used as the 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. The evaluation indexes include sensitivity, specificity, detection rate of precancerous lesions and adenoma.

Detailed description

The study is expected to complete baseline examinations of 80,000 subjects within 1 year. Community members who sign informed consent forms will complete the Colorectal cancer Risk Factor Assessment Questionnaire, history collection, and colorectal cancer polymethylation test early screening at baseline. Subjects who tested positive for polygene methylation screening for colorectal cancer will undergo a fecal immunochemistry (FIT) test, a blood carcinoembryo antigen (CEA) test, and colonoscopy within 3 months. Telephone follow-up medical history was collected at 1, 2, 3, and 4 years after baseline, and telephone follow-up survival outcomes were studied at 5 years after baseline. During the follow-up, patients diagnosed with colorectal cancer by colonoscopy will reach the study end point, and patients treated with polyps or adenomas found during colonoscopy will also reach the study end point.

Conditions

• Colorectal Cancer

Timeline

• Start date: 2022-04-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2022-04-20
• Last updated: 2023-08-29

Locations

2 sites across 1 country: China