Actively Recruiting
Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study
Led by Mayo Clinic · Updated on 2026-05-27
950
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
E
Exact Sciences Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with suspected or confirmed Lynch syndrome to evaluate a DNA screening method for detecting colorectal cancer and advanced neoplasia. The study aims to determine how well the multitarget stool DNA (mt-sDNA) 2.0 test can identify colorectal growths in these patients. Additionally, the study will create a collection of stool and blood samples from participants with Lynch syndrome and early onset colorectal cancer for future research. Participants provide blood and stool samples either up to 90 days before or between 7 to 90 days after their scheduled standard colonoscopy or flexible sigmoidoscopy. Alongside sample collection, the researchers review participants' medical records. This observational study does not involve treatment but focuses on biospecimen collection and record review to assess the DNA test's accuracy. During the study, patients undergo sample collection aligned with their routine colon exams, and their medical history is reviewed to support study goals. The main outcomes measured are the sensitivity and specificity of the mt-sDNA 2.0 test for detecting colorectal neoplasia and dysplasia, tracked for up to four years. Participants are monitored through this period to evaluate the performance of the DNA screening method.
CONDITIONS
Brief Title
Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients at least 18 years of age
- Diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or colorectal cancer with suspected Lynch syndrome
- Diagnosed with early onset colorectal cancer (under 55 years old)
- Colonoscopy or flexible sigmoidoscopy scheduled within 90 days before or after sample collection
- Agreed to participate and signed study consent form
You will not qualify if you...
- Known cancer (stage I-IV) in the past 5 years, excluding certain skin cancers
- Received chemotherapy drugs for cancer in the past 5 years
- Had abdominal radiation therapy prior to sample collection
- Prior therapy to target lesion intended to fully remove or reduce it (e.g., polypectomy, surgical resection)
- Prior diagnosis of non-Lynch hereditary colon cancer syndromes (e.g., familial adenomatous polyposis)
- Bowel preparation less than 7 days before stool collection
- Oral or rectal contrast given within 7 days before stool collection
- Presence of ileostomy
- Receiving enteral feeds or total parenteral nutrition
- Diagnosis of inflammatory bowel disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months depending on timing relative to colonoscopy or flexible sigmoidoscopy
Participants provide blood and stool samples around the time of their standard colonoscopy or flexible sigmoidoscopy. Participants' medical records are also reviewed.
1 to 2 visits depending on timing of sample collection
Trial Site Locations
Total: 9 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
3
University of Colorado Anschutz Medical Center
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
6
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
University of Washington
Seattle, Washington, United States, 98102
Actively Recruiting
Research Team
R
Rosalie Himle
C
Clinical Trials Referral Office
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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