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RecruitingObservational

Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study

NCT ID: NCT05410977Sponsor: Mayo ClinicLast updated: 2026-05-27

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 cancer in Lynch syndrome patients.

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. Develop a biorepository of samples (stool and blood) from patients with Lynch syndrome and early onset colorectal cancer. OUTLINE: 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.

Arms & interventions

  • ProcedureBiospecimen Collection

    Undergo collection of blood and stool samples

  • OtherElectronic Health Record Review

    Medical records reviewed

Outcome measures

Primary

  • Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia

    Results of the mt-sDNA 2.0 test will be correlated with pathology findings of patients undergoing colonoscopy to determine sensitivity of the mt-sDNA 2.0 test

    Time frame: Up to 4 years

  • Specificity of mt-sDNA 2.0 test to detect colorectal dysplasia

    Results of the mt-sDNA 2.0 test will be correlated with pathology findings of patients undergoing colonoscopy to determine specificity of the mt-sDNA 2.0 test

    Time frame: Up to 4 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (9)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

Recruiting
Colleen Gallagher · Contact
Clinical Trials Referral Office · Contact
Jewel Samadder, M.D. · Principal Investigator

University of California San Francisco

San Francisco, California, 94115

Recruiting
Rachael Leigh Delacruz · Contact
Aparajita Singh,, MD · Principal Investigator

University of Colorado Anschutz Medical Center

Aurora, Colorado, 80045

Recruiting
Swati Patel, MD · Principal Investigator

Mayo Clinic in Florida

Jacksonville, Florida, 32224

Recruiting
Clinical Trials Referral Office · Contact
Douglas L. Riegert-Johnson, MD · Principal Investigator

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Not Yet Recruiting
Katharine Germansky, MD · Contact
Katharine Germansky, MD · Principal Investigator

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Sapna Syngal, MD, MPH · Principal Investigator

Mayo Clinic

Rochester, Minnesota, 55905

Recruiting
Rosalie Himle · Contact
Clinical Trials Referral Office · Contact
John Kisiel, M.D. · Principal Investigator

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting
Bryson Katona, MD, PhD · Principal Investigator

University of Washington

Seattle, Washington, 98102

Recruiting
William Grady, MD · Principal Investigator