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

Launched by MAYO CLINIC · Jun 6, 2022

Keywords

ClinConnect Summary

The CORAL Study is a clinical trial aimed at finding better ways to detect colorectal cancer in patients with Lynch syndrome, a genetic condition that increases the risk of developing certain types of cancer. In this study, researchers will collect blood and stool samples from participants to evaluate a new DNA screening method. This study is currently recruiting individuals aged 18 and older who have been diagnosed with Lynch syndrome or early-onset colorectal cancer, and who have a colonoscopy or flexible sigmoidoscopy scheduled within 90 days of providing samples.

If you decide to participate, you'll need to give your consent and provide blood and stool samples for testing. It's important to note that certain factors may make you ineligible, such as having received specific cancer treatments or having certain types of cancer in the past. Participants will help advance our understanding of how to better screen for colorectal cancer in those at higher risk, and your involvement could contribute to significant improvements in patient care in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients at least 18 years of age
• • Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or suspected Lynch syndrome or individuals diagnosed with early onset colorectal cancer (CRC) (\< 50 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) 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 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
• • Removal of more than 50% of colon or presence of ileostomy
• • Enteral feeds or total parenteral nutrition (TPN)
• • Diagnosis of inflammatory bowel disease