Could a common drug curb polyps in teens with rare genetic condition?

NCT ID NCT06308445

Disease control Sponsor: University Hospital, Toulouse Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests two low doses of rapamycin, a drug usually used to prevent organ rejection, in 25 teenagers (ages 12-17) with familial adenomatous polyposis (FAP), a genetic condition that causes many colon polyps and raises cancer risk. The main goal is to see if the drug is safe and tolerable. Researchers will also check if it reduces the number or size of polyps. The study is not yet recruiting.

What this could mean

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

Active substance: Rapamycin
What this could lead to: If successful, this could point toward a way to slow or reduce polyp growth in teens with FAP, potentially delaying or avoiding surgery.
What could go wrong: This is a small, early safety study (Phase 2) with only 25 participants. Rapamycin has known side effects, and it is not yet proven to work for FAP. The results may not apply to all patients.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

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

12 to 17 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: * Children aged 12 to 17 at time of inclusion. * Patients with colonoscopy for diagnosis or follow-up of FAP. * ≥ 5 polyps (\> 2 mm) at initial colonoscopy (V1). * Free and informed consent, signed by both holders of parental authority/legal representative, with the accord of the minor patient. * Affiliated with a social security scheme. * Patients of childbearing potential must agree to the use of a method of contraception during the study. Exclusion Criteria: * Inability to understand the nature and goals of the study and/or communication difficulties observed by the investigator. * Contraindication to performing a colonoscopy. * \< 5 polyps (\>2 mm) registered during initial colonoscopy (V1). * Advanced disease with high-grade dysplasia adenoma or even adenocarcinoma in situ that should required colectomy * Signs of primary tuberculosis infection or respiratory infection * Any other medical or psychological condition deemed incompatible with the proper conduct of the study according to the investigator. * Contraindications to rapamycin use * Participation in other biomedical research * Deprivation of liberty of the legal guardians by judicial or administrative decision. * Pregnancy, breastfeeding

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Conditions

The condition(s) this trial relates to.

Adenomatous Polyposis Coli classic familial adenomatous polyposis

As listed by the trial registrant

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

Familial adenomatous polyposis

How to take part

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

The places running it

4 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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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.

Could a common drug curb polyps in teens with rare genetic condition?

What the study statuses mean