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
3 other identifiers
observational
750
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2022
CompletedFirst Submitted
Initial submission to the registry
June 6, 2022
CompletedFirst Posted
Study publicly available on registry
June 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
May 1, 2026
April 1, 2026
5 years
June 6, 2022
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
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.
Interventions
Undergo collection of blood and stool samples
Medical records reviewed
Eligibility Criteria
Adults diagnosed with Lynch syndrome or suspected Lynch syndrome or early onset colorectal cancer.
You may qualify if:
- 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
You may not qualify if:
- 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 \[familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), PTEN, POL\]
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Exact Sciences Corporationcollaborator
- Mayo Cliniclead
Study Sites (9)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
University of California San Francisco
San Francisco, California, 94115, United States
University of Colorado Anschutz Medical Center
Aurora, Colorado, 80045, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Washington
Seattle, Washington, 98102, United States
Related Links
Biospecimen
Blood, stool
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Niloy Jewel Samadder, M.D.
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2022
First Posted
June 8, 2022
Study Start
March 30, 2022
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04