RecruitingRecruiting
Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients
NCT05410977 · Mayo Clinic
In plain English
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Official title
Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study
About this study
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.
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 design
Enrollment target: 950 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-03-30
Estimated completion: 2027-12-31
Last updated: 2026-05-27
Interventions
Procedure: Biospecimen CollectionOther: Electronic Health Record Review
Primary outcomes
- • Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia (Up to 4 years)
- • Specificity of mt-sDNA 2.0 test to detect colorectal dysplasia (Up to 4 years)
Sponsor
Mayo Clinic · other
With: Exact Sciences Corporation
Contacts & investigators
ContactRosalie Himle · contact · LaMere.Rosalie@mayo.edu · 507-266-5755
ContactClinical Trials Referral Office · contact · mayocliniccancerstudies@mayo.edu · 855-776-0015
InvestigatorNiloy Jewel Samadder, M.D. · principal_investigator, Mayo Clinic
All locations (9)
Mayo Clinic in ArizonaRecruiting
Scottsdale, Arizona, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
University of Colorado Anschutz Medical CenterRecruiting
Aurora, Colorado, United States
Mayo Clinic in FloridaRecruiting
Jacksonville, Florida, United States
Beth Israel Deaconess Medical CenterNot Yet Recruiting
Boston, Massachusetts, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
University of WashingtonRecruiting
Seattle, Washington, United States