ClinicalTrials.gg
CompletedNCT05125939Updated Sep 11, 2026

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

An observational study in Adenoma Detection Rate and Colonoscopy, sponsored by Evergreen General Hospital, Taiwan. Completed at 6 sites in 2 countries. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Evergreen General Hospital, Taiwan · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,707
Ages
50 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Adenoma Detection Rate
  • Colonoscopy

Keywords

  • Colonoscopy
  • Adenoma detection rate
  • Screening
03

In context

Lead sponsor

Evergreen General Hospital, Taiwan is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,707 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Surveillance indication

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

    Other: Comparison of ADR

  • 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

  • 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

Interventions

  • OtherComparison 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.

06

What researchers measure

Primary outcomes

  1. Adenoma detection rate

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

    Time frame: 7 days

07

Study locations

6 sites
  • Sepulveda Ambulatory Care Center, VAGLAHS
    North Hills, California 91343, United States
  • E-Da Dachang Hospital
    Kaohsiung City, 80784, Taiwan
  • E-Da Hospital
    Kaohsiung City, 82445, Taiwan
  • Keelung Chang Gung Memorial Hospital
    Keelung, 204, Taiwan
  • Evergreen General Hospital
    Taoyuan, 320, Taiwan
  • Linkou Chang Gung Memorial Hospital
    Taoyuan, 333, Taiwan
08

References and documents

Publications

  • 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. PubMed 24246797 ↗
  • 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. PubMed 33618027 ↗
  • 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. PubMed 28753699 ↗
  • 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. PubMed 33895358 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2021 to primary completion in May 2026, 54 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2021
First posted
Nov 18, 2021
StartActual
Nov 20, 2021
Primary completionActual
May 31, 2026
CompletionActual
Aug 31, 2026
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05125939
Lead sponsor
Evergreen General Hospital, Taiwan
Collaborators
E-DA Hospital, E-Da Dachang Hospital, Chang Gung Memorial Hospital, Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System
Responsible party
Sponsor
First posted
Nov 18, 2021
Start date
Nov 20, 2021
Primary completion
May 31, 2026
Completion
Aug 31, 2026
Last update
Sep 11, 2026

Study contacts

Chi-Liang Cheng
principal investigator · Evergreen General Hospital, Taoyuan, Taiwan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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