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

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