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

RecruitingN/A

Sponsor: Mayo Clinic

Conditions: Colorectal Carcinoma, Lynch Syndrome

Interventions: Biospecimen Collection, Electronic Health Record Review

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Patients at least 18 years of age
* Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or colorectal cancer (CRC) with suspected Lynch syndrome or individuals diagnosed with early onset CRC (\<55 years old)
* 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) within 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 (non-hyperplastic) 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
* Presence of ileostomy
* Enteral feeds or total parenteral nutrition (TPN)
* Diagnosis of inflammatory bowel disease

Locations (9)

Scottsdale, Arizona, United States
San Francisco, California, United States
Aurora, Colorado, United States
Jacksonville, Florida, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
Philadelphia, Pennsylvania, United States
Seattle, Washington, United States