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Could a simple stool test spare thousands from repeat colonoscopies?

NCT ID NCT04967183

Prevention Sponsor: Fundacin Biomedica Galicia Sur 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests whether an annual stool-based test (FIT) can be as effective as routine colonoscopy for people who have had advanced polyps removed. Participants aged 50 to 65 from colorectal cancer screening programs will be randomly assigned to either yearly FIT or scheduled endoscopic surveillance. The study tracks rates of new colorectal cancer, advanced lesions, and complications over several years to see if the less invasive approach holds up.

What this could mean

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

Active substance
Annual fecal immunochemical test (FIT) compared with endoscopic surveillance (colonoscopy)
What this could lead to
If FIT proves non-inferior, many people could avoid frequent colonoscopies after polyp removal, easing the burden on patients and healthcare systems.
What could go wrong
The trial is large but results are not yet available. FIT may miss some lesions that colonoscopy would find, and the study only includes people already in screening programs.

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

About 3,788 people

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

Started

Jun 2022

Expected to finish

Jun 2035

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.

Ages

50 to 65 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. Individuals aged 50 to 65 years. 2. Individuals with at least one advanced adenoma (tubulovillous or villous histology, high grade dysplasia or ≥ 10mm), and / or at least three non-advanced adenomas detected and resected completely within the population-based CRC screening program. Exclusion Criteria: 1. Personal history of CRC. 2. Colonic lesion ≥10mm resected without histological diagnosis. 3. More than 10 adenomas in baseline colonoscopy. 4. Serrated polyposis syndrome. 5. Two or more first-degree relatives with CRC. 6. Hereditary predisposition to CRC. 7. Relevant comorbidity with life expectancy inferior to 5 years. 8. Colonoscopy with incomplete mucosal examination. 9. Incomplete resection of baseline lesions. 10. Non-acceptance after reading the informed consent.

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Conditions

The condition(s) this trial relates to.

colorectal neoplasm Motor Activity colorectal cancer prevention target

As listed by the trial registrant

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

Colorectal cancer

Contacts and locations

Locations

  • Complexo Hospitalario Universitario de Ourense

    Ourense, Ourense, 32002, Spain

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