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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this 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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility 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
Study sites (9)
AZ
- Mayo Clinic in Arizona · Scottsdale, AZ 85259Colleen Gallagher · Study contact · 480-574-1346 · gallagher.colleen@mayo.eduClinical Trials Referral Office · Study contact · 855-776-0015 · mayocliniccancerstudies@mayo.eduJewel Samadder, M.D. · Principal investigatorMore trials in Scottsdale
CA
- University of California San Francisco · San Francisco, CA 94115More trials in San Francisco
CO
- University of Colorado Anschutz Medical Center · Aurora, CO 80045Mahlet Haileyesus · Study contact · 303-724-6070 · mahlet.haileyesus@cuanschutz.eduSwati Patel, MD · Principal investigatorMore trials in Aurora
FL
- Mayo Clinic in Florida · Jacksonville, FL 32224Clinical Trials Referral Office · Study contact · 855-776-0015 · mayocliniccancerstudies@mayo.eduDouglas L. Riegert-Johnson, MD · Principal investigatorMore trials in Jacksonville
MA
- Beth Israel Deaconess Medical Center · Boston, MA 02215Katharine Germansky, MD · Study contact · 617-667-5661 · kgermans@bidmc.harvard.eduKatharine Germansky, MD · Principal investigatorMore trials in Boston
- Dana Farber Cancer Institute · Boston, MA 02215Rachel Yore · Study contact · 857-215-2924 · rachel_yore@dfci.harvard.eduSapna Syngal, MD, MPH · Principal investigatorMore trials in Boston
MN
- Mayo Clinic · Rochester, MN 55905Rosalie Himle · Study contact · 507-266-5755 · LaMere.Rosalie@mayo.eduClinical Trials Referral Office · Study contact · 855-776-0015 · mayocliniccancerstudies@mayo.eduJohn Kisiel, M.D. · Principal investigatorMore trials in Rochester
PA
- University of Pennsylvania · Philadelphia, PA 19104Michaela Dungan · Study contact · 215-360-0833 · michaela.dungan@pennmedicine.upenn.eduBryson Katona, MD, PhD · Principal investigatorMore trials in Philadelphia
WA
- University of Washington · Seattle, WA 98102Brian Foerster, ' · Study contact · 206-685-1179 · bfoerster@medicine.washington.eduWilliam Grady, MD · Principal investigatorMore trials in Seattle