Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients
About this study
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.
- Condition
- Colorectal Carcinoma, Lynch Syndrome
- Tested
- Biospecimen Collection, Electronic Health Record Review
- Sponsor
- Mayo Clinic
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 18 years
- Study condition: Colorectal Carcinoma, Lynch Syndrome
- 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 11
- 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
Where
9 sites, 8 recruiting
University of Colorado Anschutz Medical Center
Aurora, Colorado, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Mayo Clinic
Rochester, Minnesota, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
and 3 more sites on ClinicalTrials.gov
Contact
-
Rosalie Himle
507-266-5755 LaMere.Rosalie@mayo.edu
-
Clinical Trials Referral Office
855-776-0015 mayocliniccancerstudies@mayo.edu
Potential match only. Final eligibility is determined by the study team.