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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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]

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Electronic Health Record Review

Treatment groups

950 Participants
are divided into 1 treatment group

Locations

9
Arizona
Mayo Clinic in Arizona85259, Scottsdale United States
California
University of California San Francisco94115, San Francisco United States
Colorado
University of Colorado Anschutz Medical Center80045, Aurora United States
Florida
Mayo Clinic in Florida32224, Jacksonville United States

Sponsors and collaborators

Mayo Clinic

Lead sponsor

Exact Sciences Corporation

Collaborator