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Stool DNA test may offer easier cancer monitoring

NCT ID NCT04624555

Diagnosis Sponsor: Case Comprehensive Cancer Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a stool DNA test (mt-sDNA) can accurately detect polyps or cancer in people who have already been treated for stage I-III colorectal cancer. Researchers will compare the stool test results to colonoscopy findings in 50 survivors. The goal is to see if the stool test is a reliable and acceptable alternative for routine surveillance.

What this could mean

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

Active substance
Multi-target stool DNA (mt-sDNA) test
What this could lead to
If successful, this stool test could offer a less invasive way to monitor colorectal cancer survivors for recurrence, potentially reducing the need for frequent colonoscopies.
What could go wrong
This is a small early study with only 50 participants, so results may not apply to everyone. The stool test may miss some polyps or cancers, leading to false reassurance.

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 50 people

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

Started

Oct 2022

Expected to finish

Sep 2026

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

Participants who are diagnosed with stage I-III colorectal cancer. All participants who are within 1 year of colon cancer resection will be asked to participate in the study.

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: * Diagnosis of stage I, II or III adenocarcinoma of the colon or rectum * Receipt of preoperative colonoscopy * Receipt of bowel resection; use of adjuvant chemotherapy or radiation therapy as clinically indicated Exclusion Criteria: * Stage IV colorectal cancer * Surgical treatment with subtotal colectomy or total proctocolectomy * Diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease) * Diagnosis of polyposis syndrome including Lynch syndrome or familial polyposis * Presence of advanced adenomas (1 cm or larger, villous features and/or high grade dysplasia) that were not removed at the preoperative colonoscopy or contained in the resection specimen. * Inability to provide informed consent * Inability to understand spoken and written English * Medical comorbidities that would be contraindications to sedation or that would preclude any benefit of routine surveillance post-resection. These would be at the discretion of the participant's providers.

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Conditions

The condition(s) this trial relates to.

colon adenocarcinoma colonic neoplasm colorectal cancer colorectal carcinoma colorectal neoplasm rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Adenocarcinoma of the colon Adenocarcinoma of the rectum Stage I colorectal cancer Stage II colorectal cancer Stage III colorectal cancer

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

    1 site. 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

Locations

  • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

    Contact Email: •••••@•••••

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