Status:
RECRUITING
Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Exact Sciences Corporation
Conditions:
Colorectal Carcinoma
Lynch Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
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 cance...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the sensitivity and specificity of the multitarget stool DNA (mt-sDNA) 2.0 test, for colorectal neoplasia in patients with Lynch syndrome. SECONDARY OBJECTIVE: I....
Eligibility Criteria
Inclusion
- Patients at least 18 years of age
- Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or suspected Lynch syndrome or individuals diagnosed with early onset colorectal cancer (CRC) (\< 50 years old)
- Colonoscopy/flexible sigmoidoscopy (flex sig) scheduled +/- 90 days from sample collection
- Patient has agreed to participate and has signed the study consent form
Exclusion
- Patient has known cancer (stage I-IV) 5 years prior to current sample collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible)
- Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current sample collection
- Patient has had any abdominal radiation therapy prior to current sample collection
- Patient had therapy to the target lesion with intent to completely remove or debulk the lesion prior to sample collection \[examples include snare polypectomy, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), surgical resection, trans anal excision\]
- Patient has prior diagnosis of non-lynch hereditary colon cancer syndrome \[familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), PTEN, POL\]
- ADDITIONAL STOOL EXCLUSIONS:
- Bowel prep \< 7 days prior to stool collection
- Oral or rectal contrast given within 7 days prior to stool collection
- Removal of more than 50% of colon or presence of ileostomy
- Enteral feeds or total parenteral nutrition (TPN)
- Diagnosis of inflammatory bowel disease
Key Trial Info
Start Date :
March 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT05410977
Start Date
March 30 2022
End Date
April 1 2027
Last Update
August 17 2025
Active Locations (9)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
University of California San Francisco
San Francisco, California, United States, 94115
3
University of Colorado Anschutz Medical Center
Aurora, Colorado, United States, 80045
4
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224