Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients, CORAL Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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 (< 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.

Official Title
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Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study

Conditions
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Colorectal Carcinoma, Lynch Syndrome

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Electronic Health Record Review


Participation Criteria
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Eligibility Criteria
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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 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) ADDITIONAL STOOL EXCLUSIONS: Bowel prep < 7 days prior to stool collection Oral or rectal contrast given within 7 days prior to stool collection Removal of more than 50% of colon or presence of ileostomy Enteral feeds or total parenteral nutrition (TPN) Diagnosis of inflammatory bowel disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (biospecimen collection, record review)<br>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<br>* Undergo collection of blood and stool samples<br>Other: Electronic Health Record Review<br>* Medical records reviewed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |