Clinical Trials

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/13/23. Questions regarding updates should be directed to the study team contact.