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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorEvergreen General Hospital, Taiwan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Comparison of ADR

    Other intervention

    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.

Treatment groups

2,700 Participants
are divided into 4 treatment groups
Group A: Screening indication1 intervention
Group B: Surveillance indication1 intervention
Group C: Diagnostic indication1 intervention
Group D: Positive fecal immunochemical test1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Evergreen General Hospital, Taiwan

Lead sponsor

E-DA Hospital

Collaborator

E-Da Dachang Hospital

Collaborator

Chang Gung Memorial Hospital

Collaborator

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

Collaborator