Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study
Summary
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.
Detailed description
PRIMARY OBJECTIVE: I. To determine the sensitivity and specificity of the multitarget stool DNA (mt-sDNA) 2.0 test, for colorectal neoplasia in patients with Lynch syndrome. SECONDARY OBJECTIVE: I. Develop a biorepository of samples (stool and blood) from patients with Lynch syndrome and early onset colorectal cancer. OUTLINE: Patients undergo collection of blood and stool samples no more than 90 days prior to or between 7-90 days after standard of care colonoscopy or flexible sigmoidoscopy. Patients' medical records are also reviewed.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo collection of blood and stool samples
- OtherElectronic Health Record Review
Medical records reviewed
Outcome measures
Primary
Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia
Results of the mt-sDNA 2.0 test will be correlated with pathology findings of patients undergoing colonoscopy to determine sensitivity of the mt-sDNA 2.0 test
Time frame: Up to 4 years
Specificity of mt-sDNA 2.0 test to detect colorectal dysplasia
Results of the mt-sDNA 2.0 test will be correlated with pathology findings of patients undergoing colonoscopy to determine specificity of the mt-sDNA 2.0 test
Time frame: Up to 4 years
Eligibility criteria
Study locations (9)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
University of California San Francisco
San Francisco, California, 94115
University of Colorado Anschutz Medical Center
Aurora, Colorado, 80045
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Mayo Clinic
Rochester, Minnesota, 55905
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Washington
Seattle, Washington, 98102