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

NCT ID: NCT05125939

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-20

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adenoma Detection Rate Colonoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Comparison of ADR

Intervention Type 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.

Surveillance indication

Surveillance indication includes patients with prior colon neoplasms, including conventional adenomas and clinically significant serrated polyps.

Comparison of ADR

Intervention Type 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.

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.

Comparison of ADR

Intervention Type 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.

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.

Comparison of ADR

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

E-DA Hospital

OTHER

Sponsor Role collaborator

E-Da Dachang Hospital

UNKNOWN

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System

UNKNOWN

Sponsor Role collaborator

Evergreen General Hospital, Taiwan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chi-Liang Cheng

Role: PRINCIPAL_INVESTIGATOR

Evergreen General Hospital, Taoyuan, Taiwan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sepulveda Ambulatory Care Center, VAGLAHS

North Hills, California, United States

Site Status ACTIVE_NOT_RECRUITING

E-Da Dachang Hospital

Kaohsiung City, , Taiwan

Site Status NOT_YET_RECRUITING

E-Da Hospital

Kaohsiung City, , Taiwan

Site Status NOT_YET_RECRUITING

Keelung Chang Gung Memorial Hospital

Keelung, , Taiwan

Site Status NOT_YET_RECRUITING

Evergreen General Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chi-Liang Cheng

Role: CONTACT

0919768058

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jen-Hao Yeh, MD

Role: primary

Wen-Lun Wang, MD

Role: primary

Shuo-Wei Chen, MD

Role: primary

Chi-Liang Cheng, MD

Role: primary

+886-919768058

Chen-Ming Hsu, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Kahi CJ, Vemulapalli KC, Johnson CS, Rex DK. Improving measurement of the adenoma detection rate and adenoma per colonoscopy quality metric: the Indiana University experience. Gastrointest Endosc. 2014 Mar;79(3):448-54. doi: 10.1016/j.gie.2013.10.013. Epub 2013 Nov 15.

Reference Type BACKGROUND
PMID: 24246797 (View on PubMed)

Kaltenbach T, Gawron A, Meyer CS, Gupta S, Shergill A, Dominitz JA, Soetikno RM, Nguyen-Vu T, A Whooley M, Kahi CJ. Adenoma Detection Rate (ADR) Irrespective of Indication Is Comparable to Screening ADR: Implications for Quality Monitoring. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1883-1889.e1. doi: 10.1016/j.cgh.2021.02.028. Epub 2021 Feb 19.

Reference Type BACKGROUND
PMID: 33618027 (View on PubMed)

Rex DK, Ponugoti PL. Calculating the adenoma detection rate in screening colonoscopies only: Is it necessary? Can it be gamed? Endoscopy. 2017 Nov;49(11):1069-1074. doi: 10.1055/s-0043-113445. Epub 2017 Jul 28.

Reference Type BACKGROUND
PMID: 28753699 (View on PubMed)

Ladabaum U, Shepard J, Mannalithara A. Adenoma and Serrated Lesion Detection by Colonoscopy Indication: The ADR-ESS (ADR Extended to all Screening/Surveillance) Score. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1873-1882. doi: 10.1016/j.cgh.2021.04.027. Epub 2021 Apr 22.

Reference Type BACKGROUND
PMID: 33895358 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EGH-2022-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CRC Detection Reliable Assessment With Blood
NCT05551052 ACTIVE_NOT_RECRUITING
The National CT Colonography Trial
NCT00084929 COMPLETED NA