Clinical trial · Observational
Colorectal Adenoma Cohort
An Ambidirectional Cohort Study on Colorectal Adenoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- colorectal adenoma recurrence
- timeFrame
- 3-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who underwent colonoscopy at our institution, were diagnosed with colorectal adenoma, and underwent adenoma resection. 2. Aged between 18 and 75 years. 3. Provide written informed consent voluntarily, with willingness to comply with follow-up procedures. 4. For the retrospective cohort only: Regular follow-up colonoscopy at our institution within 1 to 5 years after adenoma resection. Exclusion Criteria: 1. Severe dysfunction of vital organs (e.g., heart, liver, kidney). 2. Psychiatric disorders that preclude normal communication or compliance with study procedures. 3. History of colorectal cancer. 4. Recent receipt of radiotherapy or chemotherapy. 5. Pregnancy or lactation.
References
Publications (2)
- BACKGROUNDHe X, Hang D, Wu K, Nayor J, Drew DA, Giovannucci EL, Ogino S, Chan AT, Song M. Long-term Risk of Colorectal Cancer After Removal of Conventional Adenomas and Serrated Polyps. Gastroenterology. 2020 Mar;158(4):852-861.e4. doi: 10.1053/j.gastro.2019.06.039. Epub 2019 Jul 11. PMID 31302144
- BACKGROUNDLoberg M, Kalager M, Holme O, Hoff G, Adami HO, Bretthauer M. Long-term colorectal-cancer mortality after adenoma removal. N Engl J Med. 2014 Aug 28;371(9):799-807. doi: 10.1056/NEJMoa1315870. PMID 25162886