Colorectal Adenoma Cohort

This is an ambidirectional cohort study aiming to develop and validate a risk prediction model for colorectal adenoma recurrence and progression. The study will enroll patients aged 18-75 years who undergo colorectal adenoma resection at the Second Affiliated Hospital of Zhejiang University School of Medicine. A retrospective cohort will include patients treated in the past 10 years with available endoscopic, pathologic, and routine laboratory data. A prospective cohort will be enrolled from the date of ethical approval until December 31, 2030, with collection of epidemiological questionnaire data, lifestyle information, blood and tissue biospecimens, and follow-up outcomes. The primary outcome is adenoma recurrence, with secondary outcomes including advanced adenoma and colorectal cancer. Based on a target of 1,083 evaluable participants (325 events) to ensure adequate model development, and accounting for 15% loss to follow-up, the total planned enrollment is 1,280 participants. The study will validate existing risk models based on traditional adenoma characteristics and establish a novel model incorporating lifestyle factors and systemic inflammatory markers to improve risk stratification and guide surveillance strategies.

NCT Number	NCT07523035
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	Colorectal Neoplasms
Enrollment	1,280 participants
Start Date	2026-04-16
Primary Completion	2030-12-31 (estimated)
Study Completion	2033-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-13