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

Part of paid clinical trials in North Hills, California.

Sponsor
Evergreen General Hospital, Taiwan
Study ID
NCT05125939
Status
Recruiting
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Conditions

  • Adenoma Detection Rate
  • Colonoscopy

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Comparison of ADR — 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.

Study Details

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.

Key Dates

Start date
Nov 20, 2021
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
2,700 participants (estimated)

Arms

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

Primary Outcome Measure

Adenoma detection rate [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sepulveda Ambulatory Care Center, VAGLAHSNorth HillsCalifornia91343-

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Sepulveda Ambulatory Care Center, VAGLAHS· North Hills, CA

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