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NCT03919487
Surrogate Quality Indicators for Adenoma Detection Rate (ADR)
trial testing Back to back colonoscopy in Colon Adenoma in 400 participants. Completed in 18 December 2020.
30 June 2020
Quick facts
| Lead sponsor | Soonchunhyang University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 1 July 2018 |
| Primary completion | 30 June 2020 |
| Estimated completion | 18 December 2020 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Back to back colonoscopy
Conditions studied
- Colon Adenoma — all drugs for Colon Adenoma →
Sponsor
Soonchunhyang University Hospital
Who can join
Adults 50 to 75, any sex, with Colon Adenoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is to evaluate the correlation of adenoma missing rate and quality indicators of colonoscopy including adenoma detection ratee (ADR), polyp detection rate (PDR), adenoma per colonoscopy rate (APC), adenoma per positive participant (APP), ADR-Plus, and to find out the surrogate indicators of ADR. This study is a prospective observational multi-center study. Correlation between AMR and quality indicators of colonoscopy based on the previous studies, 8 endoscopists participated in this study and will enroll 50 screening colonoscopies respectively. Recruit research participants who want to participate in research in outpatient clinics. Perform colonoscopy in the morning after colon cleansing with split method. Colonoscopy is performed by back-to-back two consecutive colonoscopies. When the first colonoscopy is performed, the colonoscope is retracted after inserting the cecum, and all colon polyps are removed. After retracting to the anus of the first colonoscopy, the second colonoscopy is performed immediately. In case of newly detected colon polyps except for the small polyps and S-colon and rectal polyps which were left as photographs during the first colonoscopy with the second colonoscopy, we regard them as an overlooked lesion during the first colonoscopy. After the procedure, the histologic examination is confirmed and classified as benign lesions (all adenomas, advanced adenomas, dysplasia, and colorectal cancer) and non-lesion lesions. Using the back-to-back colonoscopy results of the participants during the study period, calculate the quality indicators including ADR, PDR, APC, ADR-plus, APP and AMR for each endoscopist. And then, evaluate the correlation between AMR and other quality indicators.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Correlation between Surrogate Quality Indicators for Adenoma Detection Rate and Adenoma Miss Rate in Qualified Colonoscopy, CORE Study: KASID Multicenter Study.
Han JH, Kim HG, Ahn EM, Park S, et al · · 2022 · cited 7× · PMID 34933279 · DOI 10.5009/gnl210287
Verify or expand the search:
- PubMed search for NCT03919487
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03919487 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Soonchunhyang University Hospital
- Last refreshed: 10 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03919487.
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