Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study
Overview
- Phase
- Not Applicable
- Intervention
- Biospecimen Collection
- Conditions
- Colorectal Carcinoma
- Sponsor
- Mayo Clinic
- Enrollment
- 750
- Locations
- 18
- Primary Endpoint
- Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia
- Status
- Recruiting
- Last Updated
- yesterday
Overview
Brief 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 (\< 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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)
Arms & Interventions
Observational (biospecimen collection, record review)
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.
Intervention: Biospecimen Collection
Observational (biospecimen collection, record review)
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.
Intervention: Electronic Health Record Review
Outcomes
Primary Outcomes
Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia
Time Frame: Up to 4 years
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
Specificity of mt-sDNA 2.0 test to detect colorectal dysplasia
Time Frame: Up to 4 years
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