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 groupSponsors and collaborators
Mayo Clinic
Lead sponsor
Exact Sciences Corporation
Collaborator
Source ClinicalTrials.gov