Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05410977

Conditions

Colorectal Carcinoma

Lynch Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Electronic Health Record Review

Study Details

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.

Conditions

Colorectal Carcinoma

Lynch Syndrome

Study ID

NCT05410977

Start date

Mar 30, 2022

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

950 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen Collection

Undergo collection of blood and stool samples

Electronic Health Record Review

Medical records reviewed

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Rosalie Himle

507-266-5755LaMere.Rosalie@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Colleen Gallagher

480-574-1346gallagher.colleen@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Jewel Samadder, M.D.

University of Colorado Anschutz Medical Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Mahlet Haileyesus

303-724-6070mahlet.haileyesus@cuanschutz.edu

Principal Investigator:

Swati Patel, MD

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Douglas L. Riegert-Johnson, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Rachel Yore

857-215-2924rachel_yore@dfci.harvard.edu

Principal Investigator:

Sapna Syngal, MD, MPH

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Rosalie Himle

507-266-5755LaMere.Rosalie@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

John Kisiel, M.D.

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Michaela Dungan

215-360-0833michaela.dungan@pennmedicine.upenn.edu

Principal Investigator:

Bryson Katona, MD, PhD

University of Washington

Recruiting

Seattle, Washington, United States, 98102

Contacts

Brian Foerster, '

206-685-1179bfoerster@medicine.washington.edu

Principal Investigator:

William Grady, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-18.