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Which home test gets more people screened for colon cancer?

NCT ID NCT05714644

Knowledge-focused Sponsor: Massachusetts General Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two at-home colorectal cancer screening tests—FIT and Cologuard—in over 5,000 patients at community health centers. Participants were mailed a test kit and asked to complete it at home. The goal was to see which test had higher completion rates and was more practical for these clinics. Results will help improve screening equity in diverse communities.

What this could mean

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

Active substance
FIT kit and Cologuard screening tests
What this could lead to
If successful, this could help clinics choose the most effective home test for colorectal cancer screening, especially in underserved communities.
What could go wrong
This is a completed study comparing two existing tests, not a new treatment. Results may not apply to all populations or settings.

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

5,127 people

The number who actually took part.

Started

Jun 2023

Finished

Sep 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 75 years

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: 1. Age 45-75 2. Has had a visit at a participating community clinic within the last two years. 3. Alive 4. Patient's preferred language is English or Spanish Exclusion Criteria: Exclusion Criteria: 1. Has Ulcerative Colitis or Crohn's disease documented in the problem list. (Codes below). 2. Has colorectal cancer documented in the problem list. (Codes below). 3. Has had a FIT in the past 1 year 4. Has had a colonoscopy in the past 10 years ICD-10 codes for exclusion criteria: Ulcerative colitis: * K51.0 * K51.2 * K51.3 * K51.4 * K51.5 * K51.8 * K51.9 * K52.8 * K52.9 Crohn's disease: * K50.0 * K50.1 * K50.8 * K50.9 Colorectal cancer * C18 (malignant neoplasm of colon) * C18.0 (malignant neoplasm of cecum) * C18.1 (malignant neoplasm of appendix) * C18.2 (malignant neoplasm of ascending colon) * C18.3 (malignant neoplasm of hepatic flexure) * C18.4 (malignant neoplasm of transverse colon) * C18.5 (malignant neoplasm of splenic flexure) * C18.6 (malignant neoplasm of descending colon) * C18.7 (malignant neoplasm of sigmoid colon) * C18.8 (malignant neoplasm of overlapping sites of colon) * C18.9 (malignant neoplasm of colon, unspecified) * C19 (malignant neoplasm of rectosigmoid junction) * C20 (malignant neoplasm of rectum) * C21.8 (malignant neoplasm of overlapping sites of rectum, anus and anal canal) * C26.0 (malignant neoplasm of intestinal tract, part unspecified) * C78.5 (secondary malignant neoplasm of large intestine and rectum) * C78.6 (secondary malignant neoplasm of retroperitoneum and peritoneum) * D37.4 (neoplasm of uncertain behavior of colon) * D37.5 (neoplasm of uncertain behavior of rectum)

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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

  • Great Plains Tribal Leaders Health Board

    Rapid City, South Dakota, 57703, United States

  • Mass General Brigham

    Boston, Massachusetts, 02114, United States

  • UCLA

    Los Angeles, California, 90095-1772, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.