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Completed

NCT Number: NCT07302139

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

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

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Huadong hospital, Fudan university

Shanghai, Shanghai Municipality, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention: Observational Cohort

Other

No Intervention: Observational Cohort

Primary outcomes

  1. 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

  1. Incidence of Metachronous Colorectal Neoplasia

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

    Metachronous colorectal neoplasia is defined as any adenoma or colorectal cancer detected at any follow-up colonoscopy after the baseline index colonoscopy.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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