RecruitingNCT05410977

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

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


Sponsor

Mayo Clinic

Enrollment

750 participants

Start Date

Mar 30, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood and stool samples

OTHERElectronic Health Record Review

Medical records reviewed


Locations(9)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

University of California San Francisco

San Francisco, California, United States

University of Colorado Anschutz Medical Center

Aurora, Colorado, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Washington

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05410977


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