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Simple stool test could revolutionize colon cancer screening

NCT ID NCT00843375

Diagnosis Sponsor: University of Michigan Rogel 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

Colon cancer is common but preventable if caught early. While colonoscopy is the best screening tool, many people can't get one due to cost or time. This study collects stool and blood samples from 1,200 adults to find proteins that signal colon polyps or cancer. The goal is to develop a simpler, accurate test for early detection.

What this could mean

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

What this could lead to
If successful, this could lead to a non-invasive stool or blood test for early colon cancer detection, making screening more accessible.
What could go wrong
This is an observational study collecting samples, not testing a treatment. The biomarkers may not prove accurate enough to replace colonoscopy.

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 1,200 people

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

Started

Aug 2019

Expected to finish

Mar 2028

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

Patients diagnosed with colorectal cancer and adenomas and scheduled for surgical or endoscopic resection or subjects scheduled for a colonoscopy will be recruited from collaborating consortium centers.

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: * Willing to sign informed consent * Able to physically tolerate removal of up to 60 ml of blood * Adults at least 18 years old * Willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT) * Pregnant or nursing women who otherwise meet the eligibility criteria may participate * Subjects with one of the following: * Colorectal adenocarcinoma-not treated and in colon at time of stool collection (CRC bin) * Adenoma-pathologically confirmed adenoma present in colon at time of stool collection (Adenoma Bin) * Higher Risk Non-neoplastic Bin * Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy * Subjects with a personal history of CRC (longer than 3 years ago because of exclusion criteria of cancer within last 3 years) with none present at time of qualifying colonoscopy * Any family history of CRC (1st degree relative) * Current positive screening stool test for blood, for DNA or for both within 12 months with no follow-up intervention. * Average Risk, Non-neoplastic Bin * No history or current finding of any colorectal neoplasia including CRC, adenomas, sessile serrated adenomas and no family history of CRC. * Subjects who had CRC that was successfully treated at least three years ago may be considered eligible for the adenoma bin if their polyps are adenomas and there is no evidence of CRC, or for the higher risk non-neoplastic bin as noted above. * Subjects whose screening colonoscopy shows any of these types of polyps may be included in the non-neoplastic or the higher risk non-neoplastic bin if they meet the other criteria noted above. * Hyperplastic polyps * Benign mucosal polyps * Polypoid granulation tissue * Prolapsed mucosal polyps * Inflammatory polyp * Transitional mucosal polyp * Lipoma * Gangleoneuroma * Neuroma * Hamartomatous polyp Exclusion Criteria: * Cancer patients who have had any surgery, radiation, or chemotherapy for their current colorectal cancer prior to collecting the baseline samples * History of or clinically active Inflammatory Bowel Disease * Known HNPCC or FAP * Inability to provide informed consent. * Other active malignancy within 3 years of enrollment except any of the following: * Squamous cell carcinoma of the skin * Basal cell carcinoma of the skin * Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only. (Excluded if had pelvic radiation) * Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery * Patients on active chemotherapy or radiation treatment for any purpose * Known HIV or chronic active viral hepatitis * Women who are pregnant * CT colonography (virtual colonoscopy) patients

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal adenocarcinoma colorectal adenoma

As listed by the trial registrant

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

Colonic neoplasms

How to take part

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

  1. The places running it

    9 sites in 2 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Carle Cancer Center

    COMPLETED

    Urbana, Illinois, 61801, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Flinders Medical Center

    RECRUITING

    Adelaide, South Australia, 5001, Australia

  • Hershey Medical Center

    COMPLETED

    Hershey, Pennsylvania, 17033, United States

  • M.D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • St. Michael's Hospital

    WITHDRAWN

    Toronto, Ontario, Canada

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of North Carolina

    COMPLETED

    Chapel Hill, North Carolina, 27599, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

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