Actively Recruiting

Age: 18Years +
All Genders
NCT05410977

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

Led by Mayo Clinic · Updated on 2026-05-01

750

Participants Needed

9

Research Sites

261 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

E

Exact Sciences Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients at least 18 years of age
  • Diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or colorectal cancer with suspected Lynch syndrome
  • Individuals diagnosed with early onset colorectal cancer (under 55 years old)
  • Scheduled for colonoscopy or flexible sigmoidoscopy within 90 days before or after sample collection
  • Agreed to participate and signed the study consent form
Not Eligible

You will not qualify if you...

  • Known cancer (stage I-IV) within 5 years prior to sample collection (excluding basal cell or squamous cell skin cancers)
  • Received chemotherapy drugs for cancer treatment in the 5 years prior to sample collection
  • Had any abdominal radiation therapy before sample collection
  • Prior therapy to target lesion intended to completely remove or reduce the lesion before sample collection
  • Prior diagnosis of non-Lynch hereditary colon cancer syndromes (such as familial adenomatous polyposis, MUTYH-associated polyposis, Peutz-Jeghers syndrome, juvenile polyposis syndrome, PTEN, POL)
  • Bowel preparation less than 7 days before stool collection
  • Oral or rectal contrast given within 7 days before stool collection
  • Presence of ileostomy
  • Use of enteral feeds or total parenteral nutrition
  • Diagnosis of inflammatory bowel disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

Actively Recruiting

2

University of California San Francisco

San Francisco, California, United States, 94115

Actively Recruiting

3

University of Colorado Anschutz Medical Center

Aurora, Colorado, United States, 80045

Actively Recruiting

4

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224

Actively Recruiting

5

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Not Yet Recruiting

6

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

7

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

8

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

9

University of Washington

Seattle, Washington, United States, 98102

Actively Recruiting

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Research Team

R

Rosalie Himle

CONTACT

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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