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NCT05410977Recruiting

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

Source: ClinicalTrials.gov · Last updated 18 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
950 (estimated)
First submitted
6 Jun 2022
Start date
30 Mar 2022
Primary completion date
31 Dec 2027
Lead sponsor
Mayo Clinic
NCT number
NCT05410977

What you commit to

  • Study type: Observational
  • Planned participants: 950
  • From 30 Mar 2022 to the primary completion date, 31 Dec 2027
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 \[familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), PTEN, POL\]
  • Bowel prep \<7 days prior to stool collection
  • Oral or rectal contrast given within 7 days prior to stool collection

Other illness

  • Diagnosis of inflammatory bowel disease

Other

  • ADDITIONAL STOOL EXCLUSIONS:
  • Presence of ileostomy
  • Enteral feeds or total parenteral nutrition (TPN)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Colorado Anschutz Medical Center
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Beth Israel Deaconess Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesNot yet recruiting
Mayo Clinic in Florida
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
University of California San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesCompleted
Mayo Clinic in Arizona
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesRecruiting
University of Washington
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.