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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05410977
Recruitment Status : Recruiting
First Posted : June 8, 2022
Last Update Posted : January 18, 2024
Sponsor:
Collaborator:
Exact Sciences Corporation
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Colorectal Carcinoma Lynch Syndrome Procedure: Biospecimen Collection Other: Electronic Health Record Review

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study
Actual Study Start Date : March 30, 2022
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational (biospecimen collection, record review)
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.
 Procedure: Biospecimen Collection
Undergo collection of blood and stool samples

Other: Electronic Health Record Review
Medical records reviewed


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia [ Time Frame: Up to 4 years ]
  2. Specificity of mt-sDNA 2.0 test to detect colorectal dysplasia [ Time Frame: Up to 4 years ]

Biospecimen Retention:   Samples With DNA
Blood, stool

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults diagnosed with Lynch syndrome or suspected Lynch syndrome or early onset colorectal cancer.
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 [yo])
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05410977


Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Niloy J. Samadder, M.D.         
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Douglas L. Riegert-Johnson, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: John Kisiel, M.D.         
Sponsors and Collaborators
Mayo Clinic
Exact Sciences Corporation
Investigators
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Principal Investigator: Niloy J. Samadder, M.D. Mayo Clinic
More Information
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT05410977    
Other Study ID Numbers: 21-010010
NCI-2022-02032 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: June 8, 2022    Key Record Dates
Last Update Posted: January 18, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Syndrome
Disease
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases