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RECRUITINGOBSERVATIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) - Colonoscopy/flexible sigmoidoscopy (flex sig) scheduled +/- 90 days from sample collection - Patient has agreed to participate and has signed the study consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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) * 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

Treatments Being Tested

PROCEDURE

Biospecimen Collection

Undergo collection of blood and stool samples

OTHER

Electronic Health Record Review

Medical records reviewed

Locations (9)

Mayo Clinic in Arizona
Scottsdale, Arizona, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado Anschutz Medical Center
Aurora, Colorado, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Washington
Seattle, Washington, United States