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

Description

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.

Conditions

Colorectal Carcinoma, Lynch Syndrome

Study Overview

Study Details

Study overview

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.

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

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

Condition
Colorectal Carcinoma
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic in Arizona, Scottsdale, Arizona, United States, 85259

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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 \[yo\])
  • * Colonoscopy/flexible sigmoidoscopy (flex sig) scheduled +/- 90 days from sample collection
  • * Patient has agreed to participate and has signed the study consent form
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Niloy J. Samadder, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2026-04-01