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.
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 (\< 50 years old) 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.
Study Type
OBSERVATIONAL
Enrollment
750
Undergo collection of blood and stool samples
Medical records reviewed
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGSensitivity 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
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University of Colorado Anschutz Medical Center
Aurora, Colorado, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
NOT_YET_RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Washington
Seattle, Washington, United States
RECRUITING