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New stool test aims to improve colorectal cancer detection

NCT ID NCT04693546

Diagnosis Sponsor: Metabiomics Corp Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 aims to see how well a new stool test, called LifeKit Prevent, can detect colorectal cancer and precancerous growths (adenomas). About 12,000 adults aged 40 and older scheduled for a screening colonoscopy will provide a stool sample for the test. The results will be compared to colonoscopy findings and the standard FIT stool test to measure accuracy.

What this could mean

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

Active substance
LifeKit Prevent Colorectal Neoplasia Test (stool-based diagnostic test)
What this could lead to
If successful, this could provide a more accurate, non-invasive screening option for colorectal cancer and precancerous growths.
What could go wrong
The trial is currently suspended, and results are pending. The test may not prove accurate enough to replace current screening methods.

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 12,000 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Subjects 40 years of age and older who are eligible for colorectal cancer screening and scheduled for a screening colonoscopy per standard of care. Approximately 12,000 subjects will be targeted for enrollment.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: An individual must meet all of the criteria below to be eligible. 1. Subject is ≥ 40 years of age at the time of enrollment. 2. Subject presents for a screening colonoscopy per standard of care. 3. Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy. 4. Subject is able and willing to sign informed consent. Exclusion Criteria: An individual meeting any of the below criteria is ineligible. 1. Subject has a history of CRC or advanced precancerous lesions. 2. Subject has a diagnosis or medical history of any of the following conditions: * Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome) * Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome") * Other hereditary cancer syndromes, including but are not limited to, Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis 3. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD), including chronic ulcerative colitis or Crohn's disease. 4. Subject has a diagnosis of Cronkhite-Canada Syndrome. 5. Subject has had a positive Cologuard, fecal occult blood test or FIT within the previous 2 years. 6. Subject has undergone a colonoscopy within the previous 9 years. 7. Subject has had overt rectal bleeding within the previous 30 days. 8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

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Conditions

The condition(s) this trial relates to.

colorectal adenoma colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

Colorectal adenoma Colorectal cancer

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Solvd Health

    Carlsbad, California, 92008, United States

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