Colonoscopy vs Stool Testing for Older Adults With Colon Polyps

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT05612347
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - 82 Years
Healthy Volunteers
Not accepted

Interventions

  • FIT — DIAGNOSTIC_TEST
    Annual FIT
  • Colonoscopy — DIAGNOSTIC_TEST
    One time surveillance colonoscopy

Study Details

This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.

Key Dates

Start date
Jun 14, 2023
Status verified
May 2025
Primary completion
May 31, 2030
Completion
Dec 31, 2035

Study Design

Enrollment
8,946 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: FIT
    FIT (annual)
  • Active Comparator: Colonoscopy
    Surveillance colonoscopy (one time)

Primary Outcome Measure

Incidence of advanced neoplasia in each study group, annual FIT and colonoscopy, assessed by comparing the detection of advanced neoplasia between the two study groups. [ Time Frame: Up to 11 years ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35233-
University of ArizonaTucsonArizona85719
Joshua Melson, MD
[email protected]
5206266119
Jennifer Moreno Department of Veterans Affairs Medical CneterSan DiegoCalifornia92161
Dr. Samir Gupta
Kaiser Permanente Northern CaliforniaWalnut CreekCalifornia94596
Jeffrey Lee, MD, MPH
[email protected]
University of ColoradoAuroraColorado80045
Swati Patel, MD, MS
[email protected]
MedStar HealthWashington D.C.District of Columbia20010
Theresa Moriarty
[email protected]
2028773657
Jennifer Tran, MD (PRINCIPAL_INVESTIGATOR)
James A. Haley Veterans HospitalTampaFlorida33612-4745
Brijesh Patel, MD
[email protected]
(813) 619-5131
Northwestern Memorial HospitalChicagoIllinois60611
Zack Jacobs
[email protected]
3124729597
Rajesh Keswani, MD (PRINCIPAL_INVESTIGATOR)
Richard L. Roudebush VA Medical CenterIndianapolisIndiana46202
Thomas Imperiale, MD
[email protected]
317-988-4859
University of Michigan HealthAnn ArborMichigan48105
Nabrah Lone
[email protected]
7346473635
Stacy Menees, MD (PRINCIPAL_INVESTIGATOR)
Henry FordDetroitMichigan48202
Dr. Suraj Suresh, MD
[email protected]
313-932-5502
Dartmouth HealthLebanonNew Hampshire03756
Audrey Calderwood, MD, MS
[email protected]
(603) 650-0220
New York Harbor Health Care System - Dept of Veterans AffairsNew YorkNew York10010
Aasma Shaukat, MD
[email protected]
Kaiser Permanente NorthwestPortandOregon97232-
Oregon Health & Science University (Knight Cancer Institute)PortlandOregon97239
Seth Crockett, MD, MPH
[email protected]
(503)494-2278
University of UtahSalt Lake CityUtah84112
Andrew Gawron, MD
[email protected]
801-581-7802
Lynette Holman
Intermountain HealthSandy CityUtah84094
Dr. Christine Hachem, MD, FACG
[email protected]
8015072112
University of Virginia HealthCharlottesvilleVirginia22903
Cynthia Yoshida, MD
[email protected]
434-243-2124

Find similar trials in Birmingham, AL

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By specialty
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By research site
University of Alabama Birmingham· Birmingham, ALUniversity of Arizona· Tucson, AZJennifer Moreno Department of Veterans Affairs Medical Cneter· San Diego, CAKaiser Permanente Northern California· Walnut Creek, CAUniversity of Colorado· Aurora, COMedStar Health· Washington D.C., DC

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