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Pilot study pits cologuard against FIT for colon cancer screening in younger adults

NCT ID NCT06173375

Diagnosis Sponsor: University of California, San Diego 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
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study compared two stool-based tests—Cologuard and the fecal immunochemical test (FIT)—for colorectal cancer screening in adults aged 45-49. Researchers mailed the tests to eligible participants and tracked how many completed screening, had abnormal results, and followed up with a colonoscopy. The study involved only 12 people and aimed to see which test works better for this age group.

What this could mean

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

Active substance
Cologuard (multi-target stool DNA test) and Fecal Immunochemical Test (FIT)
What this could lead to
If successful, this could help determine which stool-based screening method is more effective for colorectal cancer detection in younger adults.
What could go wrong
This is a very small pilot study with only 12 participants, so results may not apply to larger populations. It does not test new treatments or cures.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

12 people

The number who actually took part.

Started

May 2024

Finished

Dec 2025

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.

Ages

45 to 49 years

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: * Adults ages 45-49 with EHR documentation indicating that the patient has an assigned primary care provider at UCSD Health * ≥1 UCSD Health System health visit within the last year * Resides in San Diego or Imperial County * Currently not up to date with CRC screening * Insured by private, public or other health insurance. Exclusion Criteria: * Up-to-date with screening * Prior history of colonic disease, including inflammatory bowel disease, one or more colorectal neoplastic polyps (i.e., adenomas) or colorectal cancer. * Prior history of colectomy * Lack of health insurance

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

Colorectal cancer

Contacts and locations

Locations

  • University of California San Diego

    La Jolla, California, 92126, United States

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