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Recruiting NCT05410977

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

— Observational Colorectal Carcinoma Lynch Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen Collection, Electronic Health Record Review.
Who it may be relevant to
Registry conditions: Colorectal Carcinoma, Lynch Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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 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.

Interventions

  • Procedure Biospecimen Collection
    Undergo collection of blood and stool samples
  • Other Electronic Health Record Review
    Medical records reviewed

Primary outcome measures

  • Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia [Time frame: Up to 4 years]
  • Specificity of mt-sDNA 2.0 test to detect colorectal dysplasia [Time frame: Up to 4 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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 \[familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), PTEN, POL\]
  • ADDITIONAL STOOL EXCLUSIONS:
  • Bowel prep <7 days prior to stool collection
  • Oral or rectal contrast given within 7 days prior to stool collection
  • Presence of ileostomy
  • Enteral feeds or total parenteral nutrition (TPN)
  • Diagnosis of inflammatory bowel disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 9 centers
  • Mayo Clinic in Arizona — Scottsdale
  • University of California San Francisco — San Francisco
  • University of Colorado Anschutz Medical Center — Aurora
  • Mayo Clinic in Florida — Jacksonville
  • Beth Israel Deaconess Medical Center — Boston
  • Dana Farber Cancer Institute — Boston
  • Mayo Clinic — Rochester
  • University of Pennsylvania — Philadelphia
  • … and 1 more center

Identifiers

NCT: NCT05410977 · CORAL · 21-010010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗