Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients, CORAL Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVE:
- 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:
- Develop a biorepository of samples (stool and blood) from patients with Lynch syndrome and early onset (< 50 years old) 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Procedure: Biospecimen Collection
Undergo collection of blood and stool samples
Other: Electronic Health Record Review
Medical records reviewed
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients at least 18 years of age
-
Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or suspected Lynch syndrome or individuals diagnosed with early onset colorectal cancer (CRC) (< 50 years old [yo])
-
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) 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
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Patient had therapy to the target 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)
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ADDITIONAL STOOL EXCLUSIONS:
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Bowel prep < 7 days prior to stool collection
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Oral or rectal contrast given within 7 days prior to stool collection
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Removal of more than 50% of colon or presence of ileostomy
-
Enteral feeds or total parenteral nutrition (TPN)
-
Diagnosis of inflammatory bowel disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
Sponsors and Collaborators
- Mayo Clinic
- Exact Sciences Corporation
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Niloy J Samadder, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-010010
- NCI-2022-02032
- 21-010010
- P30CA015083