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

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
Observational (biospecimen collection, record review)	Biospecimen Collection	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.
Observational (biospecimen collection, record review)	Electronic Health 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.

Primary Outcome Measures

Name	Time	Method
Specificity of mt-sDNA 2.0 test to detect colorectal dysplasia	Up to 4 years
Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia	Up to 4 years

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility