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
- Colorectal Carcinoma
- Lynch Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo collection of blood and stool samples
- Electronic Health Record Review — OTHERMedical 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
- Rosalie Himle507-266-5755
- Clinical Trials Referral Office855-776-0015
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | Jewel Samadder, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of California San Francisco | San Francisco | California | 94115 | Aparajita Singh,, MD (PRINCIPAL_INVESTIGATOR) |
| University of Colorado Anschutz Medical Center | Aurora | Colorado | 80045 | Swati Patel, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | Douglas L. Riegert-Johnson, MD (PRINCIPAL_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Katharine Germansky, MD (PRINCIPAL_INVESTIGATOR) |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Sapna Syngal, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 55905 | John Kisiel, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Bryson Katona, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Washington | Seattle | Washington | 98102 | William Grady, MD (PRINCIPAL_INVESTIGATOR) |
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