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Observational Study for Colorectal Cancer Detection in Lynch Syndrome

This study is looking at a new way to detect colorectal cancer (cancer of the large intestine) or advanced neoplasia (abnormal growths that could become cancer) in people with Lynch syndrome. Researchers are collecting blood and stool (poop) samples to test a specific DNA screening method called the multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test. The goal is to see how well this test can find these conditions in people with Lynch syndrome. You might be able to join if you are at least 18 years old, have Lynch syndrome or early-onset colorectal cancer, and have a colonoscopy or flexible sigmoidoscopy (procedures to look inside your colon) scheduled around the time of sample collection. The study aims to enroll 950 participants, but its current status is unclear.

Study design
This is an observational study, meaning participants will have blood and stool samples collected and their medical records reviewed. It aims to enroll 950 participants.
What's involved
You would provide blood and stool samples around the time of your scheduled colonoscopy or flexible sigmoidoscopy. Your medical records would also be reviewed.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the effectiveness of the mt-sDNA 2.0 test for up to 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05410977

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

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~950 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Biospecimen CollectionElectronic Health Record Review

At a glance

Recruiting sites
7 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia
Measured over Up to 4 years
+1 more outcome measured

Conditions

Colorectal Carcinoma
Lynch Syndrome

Explore related trials

Colorectal CarcinomaLynch SyndromeDNA Mismatch Repair Protein Mlh1EPCAM GeneMSH2 GeneMSH6 GenePMS2 Gene

Where it's being run

9 sites across 8 states
Massachusetts2
Arizona1
California1
Colorado1
Florida1
Minnesota1
Pennsylvania1
Washington1

Study leadership

  • Niloy Jewel Samadder, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Rosalie Himle
[email protected]
507-266-5755
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasiaUp to 4 years

    Results of the mt-sDNA 2.0 test will be correlated with pathology findings of patients undergoing colonoscopy to determine sensitivity of the mt-sDNA 2.0 test

  • Specificity of mt-sDNA 2.0 test to detect colorectal dysplasiaUp to 4 years

    Results of the mt-sDNA 2.0 test will be correlated with pathology findings of patients undergoing colonoscopy to determine specificity of the mt-sDNA 2.0 test