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Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients
RecruitingObservational study
Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Patients at least 18 years of age * Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or colorectal cancer (CRC) with suspected Lynch syndrome or individuals diagnosed with early onset CRC (\<55 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 Criteria: * Patient has known cancer (stage I-IV) within 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 (non-hyperplastic) 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 * Presence of ileostomy * Enteral feeds or total parenteral nutrition (TPN) * Diagnosis of inflammatory bowel disease
About the study
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.
What is being tested
- Biospecimen Collection (procedure)
- Electronic Health Record Review (other)
Sponsor: Mayo Clinic · Participants: 950 · Started: Mar 30, 2022
Contact the study team
- Rosalie Himle · Phone: 507-266-5755
- Clinical Trials Referral Office · Phone: 855-776-0015
Official record on ClinicalTrials.gov — NCT05410977
Locations in the U.S.
| Arizona | Mayo Clinic in Arizona, Scottsdale |
| Colorado | University of Colorado Anschutz Medical Center, Aurora |
| Florida | Mayo Clinic in Florida, Jacksonville |
| Massachusetts | Beth Israel Deaconess Medical Center, Boston (Not yet recruiting) Dana Farber Cancer Institute, Boston |
| Minnesota | Mayo Clinic, Rochester |
| Pennsylvania | University of Pennsylvania, Philadelphia |
| Washington | University of Washington, Seattle |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.