Utility of Random Biopsies in Patients With Inflammatory Bowel Disease

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT06560021
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy strategy — OTHER
    Number of random biopsies, in addition to targeted biopsies, taken during colonoscopies where at least one indication for the colonoscopy is surveillance for dysplasia

Study Details

The proposed study is a multicenter parallel group clinical trial that will include 821 evaluable patients per group who will be randomly assigned to either high definition white light colonoscopy (HDWLC) with targeted biopsies plus 2 random biopsies in 4 segments to assess for inflammation (limited biopsy strategy) or HDWLC with targeted biopsies plus 4 biopsies every 10 cm throughout the colon, at a minimum in all segments of the colon known to have been affected by IBD at any time, regardless of the extent of disease (random biopsy strategy). Participants will be followed until total proctocolectomy or the end of the study period to determine whether the two methods of surveillance colonoscopy are associated with detection of dysplasia or sessile serrated adenoma at follow-up colonoscopy. Follow-up via chart review may continue for up to 15 years from enrollment.

Key Dates

Start date
Jan 3, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
1,642 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Limited biopsy strategy
    Targeted biopsies plus 2 random biopsies in 2 segments to assess for inflammation
  • Active Comparator: Random biopsy strategy
    Targeted biopsies plus 4 biopsies every 10 cm throughout the colon, at a minimum in all segments of the colon known to have been affected by IBD at any time

Primary Outcome Measure

number of dysplastic or SSA lesions detected per colonoscopy [ Time Frame: At index colonoscopy ]

Locations (20)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35233-
University of California, Los AngelesLos AngelesCalifornia90095-
Scripps HealthSan DiegoCalifornia92121-
University of ColoradoAuroraColorado80045-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
University of MiamiMiamiFlorida33136-
AdventHealthOrlandoFlorida32804-
Northwestern UniversityChicagoIllinois60611-
Mercy Medical CenterBaltimoreMaryland21202-
University of MichiganAnn ArborMichigan48109-
Mayo Clinic RochesterRochesterMinnesota55905-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
NYU Langone HealthNew YorkNew York10016-
University of RochesterRochesterNew York14642-
University of North CarolinaChapel HillNorth Carolina27599-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Allegheny Health NetworkPittsburghPennsylvania15224-
University of PittsburghPittsburghPennsylvania15213-
Houston Methodist HospitalHoustonTexas77030-
University of UtahSalt Lake CityUtah84112-

Find similar trials in Birmingham, AL

By condition
Crohn's diseaseUlcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
University of Alabama Birmingham· Birmingham, ALUniversity of California, Los Angeles· Los Angeles, CAScripps Health· San Diego, CAUniversity of Colorado· Aurora, COMayo Clinic Jacksonville· Jacksonville, FLUniversity of Miami· Miami, FL

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