Collecting blood and stool samples to detect colorectal cancer in Lynch syndrome patients
Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study
This study is testing a new stool DNA test to see if it can help find colorectal cancer in people with Lynch syndrome by collecting their blood and stool samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 9 sites (Scottsdale, Arizona and 8 other locations) |
| Trial ID | NCT05410977 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of a multitarget stool DNA test for detecting colorectal neoplasia in patients with Lynch syndrome. Participants will provide blood and stool samples, which will be collected within a specific timeframe around their scheduled colonoscopy or flexible sigmoidoscopy. The study also seeks to create a biorepository of these samples for future research. Medical records of the participants will be reviewed to gather additional data.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with Lynch syndrome or those with early onset colorectal cancer under the age of 50.
Not a fit: Patients with known cancer stages I-IV or those who have received certain cancer treatments in the past five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of colorectal cancer in patients with Lynch syndrome, potentially saving lives.
How similar studies have performed: Other studies have shown promise in using DNA screening techniques for cancer detection, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Scottsdale, Arizona and 8 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- University of Colorado Anschutz Medical Center — Aurora, Colorado, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Not_yet_recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Niloy Jewel Samadder, M.D. — Mayo Clinic
- Study coordinator: Rosalie Himle
- Email: LaMere.Rosalie@mayo.edu
- Phone: 507-266-5755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.