Risk of Metachronous Advanced Colorectal Neoplastic Among Individuals With Varying Numbers of Non-Advanced Adenomas Detected During Screening Colonoscopy

NCT07302139 | Completed

• 1 other identifier: 2025K369
• Study Type: observational
• Target: 2,955
• Locations: 1 country
• Sites: 1

Brief Summary

A retrospective observational study to evaluate the risk of metachronous advanced colorectal neoplastic (ACRN) among individuals with varying numbers of non-advanced adenomas (NAA) detected during screening colonoscopy

Conditions

Colorectal Adenoma

Keywords

Screening colonoscopy; Surveillance; Advanced colorectal adenoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Metachronous Advanced Colorectal Neoplasia

  Metachronous advanced colorectal neoplasia is defined as advanced adenoma (≥10 mm, villous component, or high-grade dysplasia) or colorectal cancer detected at any follow-up colonoscopy after the baseline index colonoscopy.

  Through study completion, an average of 1 month

Secondary Outcomes (1)

• Incidence of Metachronous Colorectal Neoplasia

  Through study completion, an average of 1 month

Study Arms (3)

Individuals with <3 NAAs detected during screening colonoscopy

Individuals with \<3 non-advanced adenomas detected during screening colonoscopy

Other: No Intervention: Observational Cohort

Individuals with 3-4 NAAs detected during screening colonoscopy

Individuals with 3-4 non-advanced adenomas detected during screening colonoscopy

Other: No Intervention: Observational Cohort

Individuals with >4 NAAs detected during screening colonoscopy

Individuals with \>4 non-advanced adenomas detected during screening colonoscopy

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No Intervention: Observational Cohort

Individuals with 3-4 NAAs detected during screening colonoscopy; Individuals with <3 NAAs detected during screening colonoscopy; Individuals with >4 NAAs detected during screening colonoscopy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who underwent their first-time screening colonoscopy between 2012 and 2023 at the endoscopy centers of Huadong Hospital and Shanghai Tongji Hospital, and who completed at least one surveillance colonoscopy.

You may qualify if:

• First-time screening colonoscopy
• Only non-advanced adenomas (no villous features, no high-grade dysplasia, and diameter \<10 mm) were detected during first-time screening colonoscopy
• Individuals with at least one surveillance colonoscopy
• Complete electronic medical record and pathology information

You may not qualify if:

• Inadequate bowel preparation (BBPS \< 6)
• Emergency colonoscopy
• History of colorectal cancer
• Incomplete pathology information or incompletely resected polyps
• Screening colonoscopies performed by endoscopists with a low dynamic adenoma detection rate (ADR \< 15%)
• Follow-up duration \< 6 months

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huadong hospital, Fudan university

Shanghai, Shanghai Municipality, 200040, China

Location

Study Officials

• Danian Ji, M.D.

  Huadong Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 29, 2025
• First Posted: December 24, 2025
• Study Start: September 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year after completion of this study
• Access Criteria: All researchers can require the original data from principal investigator of this study (Email address: arctg4@163.com)

Locations

CN (1)