Adenoma Detection RateNCT05125939
Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study
An observational study of Adenoma Detection Rate and Colonoscopy, run by Evergreen General Hospital, Taiwan at 6 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Adenoma Detection Rate, Colonoscopy
- What is being tested?
- Comparison of ADR
- How many people
- 2,707 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 20 Nov 2021to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Adult, Older adult
Study population: All patients aged ≥50 years undergoing screening, surveillance, diagnostic, and FIT+ colonoscopy are eligible for enrollment in this study.
Who may be able to join
- consecutive patients aged ≥50 years undergoing colonoscopy are eligible for enrollment.
Who cannot join
- 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
Show all 11Show fewer
- current participation in other studies
- hospitalized patients
- mental retardation
- pregnancy
- refusal to provide a written informed consent.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Taiwan5 sites
E-Da Dachang Hospital
Kaohsiung City, 80784
E-Da Hospital
Kaohsiung City, 82445
Keelung Chang Gung Memorial Hospital
Keelung, 204
Evergreen General Hospital
Taoyuan, 320
Linkou Chang Gung Memorial Hospital
Taoyuan, 333
United States1 site
Sepulveda Ambulatory Care Center, VAGLAHS
North Hills, California, 91343
About this study
Official title: 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.
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.
- Conditions
- Adenoma Detection Rate, Colonoscopy
- Being tested
- Comparison of ADR
- Keywords
- Colonoscopy, Adenoma detection rate, Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of ADROther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Comparison of ADR | |
| Surveillance indication | Surveillance indication includes patients with prior colon neoplasms, including conventional adenomas and clinically significant serrated polyps. Receives: 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. Receives: 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. Receives: Other: Comparison of ADR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
The proportion of participants undergoing a complete colonoscopy who have one or more adenomas detected
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start20 Nov 2021
- Primary completion31 May 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adenoma Detection RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,707 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evergreen General Hospital, Taiwan
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Chi-Liang Cheng, Principal investigator, Evergreen General Hospital, Taoyuan, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125939
- Sponsor's protocol ID
- EGH-2022-1
- Status last verified
- Sep 2026
- First submitted
- 7 Nov 2021
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 24246797Kaltenbach 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 33618027Rex 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 28753699Ladabaum 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Colonoscopy Adenoma Detection Metrics by Extending the Screening-only Measurement to All Indications: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT05125939
- Acronym / sponsor ID
- EGH-2022-1
- Conditions
- Adenoma Detection Rate, Colonoscopy
- Keywords
- Colonoscopy, Adenoma detection rate, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,707 participants (actual)
- Lead sponsor
- Evergreen General Hospital, TaiwanUniversity, hospital or other
- Collaborators
- E-DA Hospital, E-Da Dachang Hospital, Chang Gung Memorial Hospital, Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Screening indication | – | Other: Comparison of ADRScreening 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. |
| Surveillance indication | – | Other: Comparison of ADRSurveillance indication includes patients with prior colon neoplasms, including conventional adenomas and clinically significant serrated polyps. |
| Diagnostic indication | – | Other: Comparison of ADRDiagnostic 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. |
| Positive fecal immunochemical test | – | Other: Comparison of ADRFIT+ 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients aged ≥50 years undergoing screening, surveillance, diagnostic, and FIT+ colonoscopy are eligible for enrollment in this study.
Key inclusion criteria (1 listed)
- consecutive patients aged ≥50 years undergoing colonoscopy are eligible for enrollment.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of ADRThe 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. | Other | Diagnostic indication, Positive fecal immunochemical test, Screening indication, Surveillance indication |
Primary outcome
Adenoma detection rate
Time frame: 7 days
The proportion of participants undergoing a complete colonoscopy who have one or more adenomas detected
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Results publication: PubMed 24246797Kahi 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.
- Results publication: PubMed 33618027Kaltenbach 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.
- Results publication: PubMed 28753699Rex 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.
- Results publication: PubMed 33895358Ladabaum 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-Liang Cheng principal investigator
Evergreen General Hospital, Taoyuan, Taiwan
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenoma Detection Rate and Colonoscopy, run by Evergreen General Hospital, Taiwan at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05125939, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.