NCT05410977

Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients

Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 750 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Carcinoma
• Lynch Syndrome

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood and stool samples
OTHER	Electronic Health Record Review	Medical records reviewed

Timeline

• Start date: 2022-03-30
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2022-06-08
• Last updated: 2025-08-17

Locations

9 sites across 1 country: United States