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

August 4, 2025 updated by: Evergreen General Hospital, Taiwan

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

2700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 80784
        • Not yet recruiting
        • E-Da Dachang Hospital
        • Contact:
      • Kaohsiung, Taiwan, 82445
      • Keelung, Taiwan, 204
        • Not yet recruiting
        • Keelung Chang Gung Memorial Hospital
        • Contact:
      • Taoyuan, Taiwan, 320
        • Recruiting
        • Evergreen General Hospital
        • Contact:
      • Taoyuan, Taiwan, 333
        • Not yet recruiting
        • Linkou Chang Gung Memorial Hospital
        • Contact:
  • United States
    • California
      • North Hills, California, United States, 91343
        • Active, not recruiting
        • Sepulveda Ambulatory Care Center, VAGLAHS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients aged ≥50 years undergoing screening, surveillance, diagnostic, and FIT+ colonoscopy are eligible for enrollment in this study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Screening indication
Screening indication includes asymptomatic patients aged ≥50 years with no prior colonoscopy and at average risk of CRC. Screening indication also includes asymptomatic patients with negative prior colonoscopy.
Other: Comparison of ADR
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.
Surveillance indication
Surveillance indication includes patients with prior colon neoplasms, including conventional adenomas and clinically significant serrated polyps.
Other: Comparison of ADR
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.
Diagnostic indication
Diagnostic indication includes patients who report symptoms (e.g., abdominal pain, a change in bowel habits, or rectal bleeding) before their first screening examination and undergo evaluation of an abnormality on other image study, unexplained anemia and/or unexplained weight loss.
Other: Comparison of ADR
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.
Positive fecal immunochemical test
FIT+ indication includes patients who undergo colonoscopy for positive FIT results in screen-eligible individuals. FIT+ indication also applies to those with a positive FIT result and a recent colonoscopy.
Other: Comparison of ADR
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: 7 days
The proportion of participants undergoing a complete colonoscopy who have one or more adenomas detected
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evergreen General Hospital, Taiwan

Collaborators

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

Investigators

  • Principal Investigator: Chi-Liang Cheng, Evergreen General Hospital, Taoyuan, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

November 7, 2021

First Submitted That Met QC Criteria

November 7, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGH-2022-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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