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New tool could better predict duodenal cancer in FAP patients

NCT ID NCT07199127

Knowledge-focused Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 aims to create a more accurate way to predict duodenal cancer risk in people with familial adenomatous polyposis (FAP), a genetic condition that greatly increases the chance of developing this cancer. Researchers will analyze endoscopy images from 300 participants to develop and test new risk models. The goal is to improve early detection and guide better surveillance or treatment decisions.

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 300 people

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

Started

Feb 2018

Expected to finish

Jan 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.

Who is studied

Individuals with familial adenomatous polyposis, defined by a pathogenic/likely pathogenic germline Adenonomatous Polyposis Coli (APC) gene variant, undergoing surveillance for duodenal polyposis using esophagogastroduondeoscopy (EGD)

Ages

18 years and older

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: * Confirmed germline diagnosis of FAP, as defined by genetic testing * Two or more upper gastrointestinal endoscopies * Complete documentation of all Spigelman classification variables at each endoscopic evaluation Exclusion Criteria: * Histological grading of duodenal polyps incomplete * Follow-up data were unavailable * Duodenal surgery before study baseline endoscopy

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Conditions

The condition(s) this trial relates to.

Adenomatous Polyposis Coli ampulla of vater cancer ampulla of vater neoplasm classic familial adenomatous polyposis duodenal villous adenoma duodenum cancer periampullary adenoma tumor of duodenum

As listed by the trial registrant

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

Ampulla of vater adenoma Ampulla of vater cancer Duodenal adenoma Duodenal neoplasms Duodenal polyposis Duodenum cancer Familial adenomatous polyposis FAP Fap gene mutation

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

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

    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

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, MI, 20129, Italy

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