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Could a simple stool test spot cancer early in lynch syndrome patients?

NCT ID NCT05410977

Diagnosis Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This study is testing a new stool DNA test (mt-sDNA 2.0) to see how well it detects colorectal cancer or advanced growths in people with Lynch syndrome, a genetic condition that raises cancer risk. Researchers will collect blood and stool samples from 950 participants and compare test results with findings from colonoscopy. The goal is to find a less invasive way to screen for cancer in this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
stool DNA test (mt-sDNA 2.0)
What this could lead to
If successful, this could lead to a simple, non-invasive stool test to catch colorectal cancer early in people with Lynch syndrome, potentially reducing the need for frequent colonoscopies.
What could go wrong
This is an early-stage study focused on accuracy, not treatment. The test may not be sensitive or specific enough to replace current screening methods, and results may not apply to the general population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 950 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults diagnosed with Lynch syndrome or suspected Lynch syndrome or early onset colorectal cancer.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm Colorectal Neoplasms, Hereditary Nonpolyposis Lynch syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal carcinoma Lynch syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beth Israel Deaconess Medical Center

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

  • Mayo Clinic in Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

    Contact Email: •••••@•••••

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

    Contact Email: •••••@•••••

  • University of California San Francisco

    COMPLETED

    San Francisco, California, 94115, United States

  • University of Colorado Anschutz Medical Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98102, United States

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