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NCT Number: NCT05125939

Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study

This is a prospective equivalence colonoscopy study evaluating whether overall adenoma detection rate (ADR) is a reliable alternate for screening ADR. Overall indication includes screening, surveillance, and diagnostic indications.

Recruiting

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

E-Da Dachang Hospital, Kaohsiung City, Taiwan

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About this study

This multicenter study will be conducted by 18 colonoscopists from 5 hospitals in Taiwan, including Evergreen general hospital, E-da hospital, E-da Dachang hospital, Linkou Chang Gung memorial hospital, and Keelung Chang Gung memorial hospital, and plans to recruit 2700 prospective participants in a 2-year period. Felix W. Leung from Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System (USA) will be involved in the study design, and will participate in data analyses and report preparation. Consecutive patients aged ≥50 years undergoing colonoscopy are eligible for enrollment. Positive fecal immunochemical test (FIT+) is considered as an independent indication category and the colonoscopy indications are categorized into 4 groups: screening, surveillance, diagnostic, and FIT+. Overall indication will be subdivided into overall excluding FIT (overall-non-FIT) group and overall including FIT (overall-FIT) group. In this study, the investigators plan to (1) compare individual ADR across 4 colonoscopy indication categories (screening, surveillance, diagnostic, FIT+); (2) explore correlations between screening ADR and overall-non-FIT and overall-FIT ADRs, respectively.

Who can participate

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

Inclusion criteria

  • consecutive patients aged ≥50 years undergoing colonoscopy are eligible for enrollment.

Exclusion criteria

  • high risk family history of colorectal cancer (CRC) e.g., familial adenomatous polyposis, hereditary non-polyposis CRC syndrome, multiple first degree relatives with CRC, or a single first degree relative with CRC at <60 years
  • serrated polyposis syndrome
  • inflammatory bowel disease
  • colonoscopy to remove a large neoplastic polyps
  • obstructive lesions of the colon
  • gastrointestinal bleeding
  • current participation in other studies
  • hospitalized patients
  • mental retardation
  • pregnancy
  • refusal to provide a written informed consent.

Treatment and study plan

Comparison of ADR

Other

The investigators will compare ADRs using traditional screening-restricted definition and combined screening, surveillance, and diagnostic indication (i.e., overall-non-FIT indication). The impact of addition of FIT+ indication into the overall indication (i.e., overall-FIT indication) on ADR will also be evaluated.

Primary outcomes

  1. Adenoma detection rate

    Time frame: 7 days

    The proportion of participants undergoing a complete colonoscopy who have one or more adenomas detected

Study contacts

Contact information is provided by the study sponsor or research team.

Chi-Liang Cheng

CONTACT

[email protected]

0919768058

Sponsors and collaborators

Lead sponsor

Evergreen General Hospital, Taiwan

Other

Collaborators

  • Chang Gung Memorial Hospital
  • E-DA Hospital
  • E-Da Dachang Hospital
  • Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System

Registry information

Official study title

Improving Colonoscopy Adenoma Detection Metrics by Extending the Screening-only Measurement to All Indications: a Prospective Multicenter Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2021
Registry last updated
Aug 7, 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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