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

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.

Study Overview

• Status: Recruiting
• Conditions: Lynch Syndrome; Colorectal Carcinoma
• Intervention / Treatment: Other: Electronic Health Record Review; Procedure: Biospecimen Collection

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.

• Study Type: Observational
• Enrollment (Estimated): 950

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Rosalie Himle; Phone Number: 507-266-5755; Email: LaMere.Rosalie@mayo.edu

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Contact: Colleen Gallagher; Phone Number: 480-574-1346; Email: gallagher.colleen@mayo.edu
      • Principal Investigator: Jewel Samadder, M.D.
  • California
    • San Francisco, California, United States, 94115
      • Recruiting
      • University of California San Francisco
      • Contact: Rachael Leigh Delacruz; Phone Number: 415-514-8087; Email: Rachaelleigh.delacruz@ucsf.edu
      • Principal Investigator: Aparajita Singh,, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Center
      • Contact: Mahlet Haileyesus; Phone Number: 303-724-6070; Email: mahlet.haileyesus@cuanschutz.edu
      • Principal Investigator: Swati Patel, MD
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic in Florida
      • Principal Investigator: Douglas L. Riegert-Johnson, MD
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
      • Contact: Rachel Yore; Phone Number: 857-215-2924; Email: rachel_yore@dfci.harvard.edu
      • Principal Investigator: Sapna Syngal, MD, MPH
    • Boston, Massachusetts, United States, 02215
      • Not yet recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Katharine Germansky, MD; Phone Number: 617-667-5661; Email: kgermans@bidmc.harvard.edu
      • Principal Investigator: Katharine Germansky, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: John Kisiel, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Contact: Rosalie Himle; Phone Number: 507-266-5755; Email: LaMere.Rosalie@mayo.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Principal Investigator: Bryson Katona, MD, PhD
      • Contact: Michaela Dungan; Phone Number: 215-360-0833; Email: michaela.dungan@pennmedicine.upenn.edu
  • Washington
    • Seattle, Washington, United States, 98102
      • Recruiting
      • University of Washington
      • Principal Investigator: William Grady, MD
      • Contact: Brian Foerster; Phone Number: 206-685-1179; Email: bfoerster@medicine.washington.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with Lynch syndrome or suspected Lynch syndrome or early onset colorectal cancer.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (biospecimen collection, record review); 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.	Other: Electronic Health Record Review; Medical records reviewed; Procedure: Biospecimen Collection; Undergo collection of blood and stool samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Up to 4 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Exact Sciences Corporation
• Investigators: Principal Investigator: Niloy Jewel Samadder, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Genetic Diseases, Inborn; Metabolic Diseases; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Neoplastic Syndromes, Hereditary; DNA Repair-Deficiency Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Colorectal Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis
• Other Study ID Numbers: CORAL; 21-010010 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No