Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05410977
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and stool samples
  • Electronic Health Record Review — OTHER
    Medical records reviewed

Study Details

This study collects blood and stool samples from patients with suspected or diagnosed Lynch syndrome to evaluate a deoxyribonucleic acid (DNA) screening technique for the detection of colorectal cancer in Lynch syndrome patients.

Key Dates

Start date
Mar 30, 2022
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
950 participants (estimated)

Arms

  • Arm: Observational (biospecimen collection, record review)
    Patients undergo collection of blood and stool samples no more than 90 days prior to or between 7-90 days after standard of care colonoscopy or flexible sigmoidoscopy. Patients' medical records are also reviewed.

Primary Outcome Measure

Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia [ Time Frame: Up to 4 years ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Colleen Gallagher
480-574-1346
Clinical Trials Referral Office
855-776-0015
Jewel Samadder, M.D. (PRINCIPAL_INVESTIGATOR)
University of California San FranciscoSan FranciscoCalifornia94115
Rachael Leigh Delacruz
415-514-8087
Aparajita Singh,, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado Anschutz Medical CenterAuroraColorado80045
Mahlet Haileyesus
303-724-6070
Swati Patel, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224
Clinical Trials Referral Office
855-776-0015
Douglas L. Riegert-Johnson, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Katharine Germansky, MD
617-667-5661
Katharine Germansky, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Rachel Yore
857-215-2924
Sapna Syngal, MD, MPH (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Rosalie Himle
507-266-5755
Clinical Trials Referral Office
855-776-0015
John Kisiel, M.D. (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Michaela Dungan
215-360-0833
Bryson Katona, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98102
Brian Foerster
206-685-1179
William Grady, MD (PRINCIPAL_INVESTIGATOR)

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