NCT07523035

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,280

participants targeted

Target at P75+ for all trials

Timeline
94mo left

Started Apr 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

April 16, 2026

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.7 years

First QC Date

April 5, 2026

Last Update Submit

April 5, 2026

Conditions

Keywords

colorectal neoplasmssurveillance

Outcome Measures

Primary Outcomes (1)

  • colorectal adenoma recurrence

    3-year

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent adenoma resection

You may qualify if:

  • Patients who underwent colonoscopy at our institution, were diagnosed with colorectal adenoma, and underwent adenoma resection.
  • Aged between 18 and 75 years.
  • Provide written informed consent voluntarily, with willingness to comply with follow-up procedures.
  • For the retrospective cohort only: Regular follow-up colonoscopy at our institution within 1 to 5 years after adenoma resection.

You may not qualify if:

  • Severe dysfunction of vital organs (e.g., heart, liver, kidney).
  • Psychiatric disorders that preclude normal communication or compliance with study procedures.
  • History of colorectal cancer.
  • Recent receipt of radiotherapy or chemotherapy.
  • Pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • He 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: 31302144BACKGROUND
  • Loberg 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: 25162886BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jun Li

    The 2nd affiliated hospital, Zhejiang University school of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2026

First Posted

April 13, 2026

Study Start

April 16, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2033

Last Updated

April 13, 2026

Record last verified: 2026-04