RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-30

Study Completion:2026-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05410977

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 \[yo\]) * Colonoscopy/flexible sigmoidoscopy (flex sig) scheduled +/- 90 days from sample collection * Patient has agreed to participate and has signed the study consent form	* 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

Inclusion Criteria

Exclusion 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 \[yo\])
* Colonoscopy/flexible sigmoidoscopy (flex sig) scheduled +/- 90 days from sample collection
* Patient has agreed to participate and has signed the study consent form

* 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

Contacts and Locations

Principal Investigator

Niloy J. Samadder, M.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

United States

Mayo Clinic in Florida

Jacksonville, Florida, 32224

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Niloy J. Samadder, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-30

Study Completion Date2026-04-01

Study Record Updates

Study Start Date2022-03-30

Study Completion Date2026-04-01

Terms related to this study

Additional Relevant MeSH Terms

Colorectal Carcinoma
Lynch Syndrome