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

https://www.facingourrisk.org/research-clinical-trials/study/256/early-detection-of-colorectal-cancer-for-people-with-lynch-syndrome

Clinicaltrials.gov identifier:
NCT05410977 (https://clinicaltrials.gov/show/NCT05410977)

Prevention
People with Lynch Syndrome at risk for colon cancer

Study Contact Information:

For additional information, please contact: the Clinical Trials Referral Office by phone 855-776-0015 or by email [email protected]

About the Study

This study will determine the effectiveness of a screening technique, multitarget stool DNA testing, for the detection of colorectal cancer in individuals with Lynch syndrome. Multitarget stool DNA testing uses stool samples to look for signs of colon cancer. This study will also create a collection of blood and stool samples from individuals with Lynch syndrome and early onset colorectal cancer (diagnosed younger than 50 years old).

What the Study Involves

Patients will give blood and stool samples no more than 90 days before or between 7-90 days after their routine colonoscopy or flexible sigmoidoscopy (using a flexible tube with a video camera to examine the colon and rectum.). Patients will also give the researchers permission to look at their medical records.

Study Sites

Arizona

Mayo Clinic in Arizona
Scottsdale, Arizona
Contact: Clinical Trials Referral Office 855-776-0015 [email protected]

Florida

Mayo Clinic in Florida
Jacksonville, Florida
Contact: Clinical Trials Referral Office 855-776-0015 [email protected]

Minnesota

Mayo Clinic
Rochester, Minnesota
Contact: Clinical Trials Referral Office 855-776-0015 [email protected]

This Study is Open To:

Patients 18 years or older who have:

A diagnosis of Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, or EPCAM) OR who have suspected Lynch syndrome OR who have been diagnosed with early onset colorectal cancer (diagnosed younger than 50 years old)
A colonoscopy OR flexible sigmoidoscopy scheduled 90 days before or after sample collection

This Study is Not Open To:

People who do not meet the inclusion criteria defined above and those who:

Have had cancer in the 5 years before sample collection (not including some skin cancers)
Have had chemotherapy for cancer treatment in the 5 years before sample collection
Have had abdominal radiation before sample collection
Have had therapy to remove or shrink a colorectal lesion before sample collection
Have a diagnosis of non-Lynch hereditary colon cancer syndrome such as familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), PTEN, or POL

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.