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Clinical Trials/NCT07302139
NCT07302139
Completed
Not Applicable

Risk of Metachronous Advanced Colorectal Neoplastic Among Individuals With Varying Numbers of Non-Advanced Adenomas Detected During Screening Colonoscopy: A Retrospective Observational Study

Fudan University1 site in 1 country2,955 target enrollmentStarted: September 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
2,955
Locations
1
Primary Endpoint
Incidence of Metachronous Advanced Colorectal Neoplasia

Overview

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

Detailed Description

Colorectal cancer (CRC) is the third most commonly diagnosed malignancy worldwide and the second leading cause of cancer-related mortality. In recent years, with increasing westernization of diet and lifestyle, both the incidence and prevalence of CRC in China have risen sharply. CRC has become the most common gastrointestinal malignancy in the country, ranking second in incidence and fifth in mortality among all cancers. Screening colonoscopy and appropriate surveillance intervals can substantially reduce CRC-related deaths.

The latest 2020 U.S. Multi-Society Task Force (USMSTF) guidelines classify patients with 1-2 non-advanced adenomas (NAAs), 3-4 NAAs, and >4 NAAs as having low-, intermediate-, and high-risk colonoscopic findings, respectively, and recommend surveillance intervals of 7-10 years, 3-5 years, and 3 years for these groups. However, accumulating evidence suggests that the risk of developing metachronous advanced colorectal neoplastic lesions (ACRN) in individuals with 3-4 NAAs may be comparable to those with only 1-2 NAAs, raising concerns regarding the appropriateness of current surveillance recommendations.

Using a real-world, endoscopy database, this study systematically evaluates the association between different NAA counts and the subsequent risk of ACRN, providing evidence to inform optimization of post-polypectomy surveillance intervals.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Incidence of Metachronous Advanced Colorectal Neoplasia

Time Frame: Through study completion, an average of 1 month

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.

Secondary Outcomes

  • Incidence of Metachronous Colorectal Neoplasia(Through study completion, an average of 1 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhijun Bao

Director

Fudan University

Study Sites (1)

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