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Study aims to personalize treatment for rare gut tumors

NCT ID NCT06356467

Knowledge-focused Sponsor: IRCCS San Raffaele 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how factors like age, sex, tumor grade, and location influence how well treatments work for people with well-differentiated gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs). Researchers will follow 450 patients to see how long their disease stays under control with common therapies. The goal is to better predict which treatments are best for each patient.

What this could mean

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

What this could lead to
If successful, this could help doctors better predict which treatments work best for different patients with GEP-NENs, leading to more personalized care.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test new therapies. Results may not change practice immediately.

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 450 people

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

Started

Nov 2023

Expected to finish

Dec 2026

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

Patients with well differentiated GEP-NENs

Ages

18 years and older

Sex

Anyone

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: * Age \>= 18 * Well-differentiated, localized (but not suitable for surgical treatment) or advanced (locally or with distant metastasis) GEP-NENs * availability of data on site of primary tumor, stage of the, date of diagnosis * treated with one (or more) of the following therapies: * Somatostatin analogs * G1 or G2 (Ki67 \<10%) GEP-NENs * Treated for at least 6 months * first-line therapy (or as second-line after surgery in patients with residual disease or recurrence after surgical resection) * Sunitinib/Everolimus * G1/G2 GEP-NENs * Treated for at least 6 months * first- or second-line therapy * Capecitabine-Temozolomide (CAP-TEM) * G2 or G3 (Ki67 \< 55%) GEP-NENs * first-, second-, or third-line therapy * Treated for at least 6 months Exclusion Criteria: * Age \< 18aa * Patients concomitantly treated with loco-regional treatments * Patients previously treated with radioligand therapy * Patients with need of CAP-TEM dose reduction of more than 33% for at least 3 administrations * NENs of unknown primitivity (including patients with biopsy on secondary lesion compatible with metastasis from GEP-NEN, but with occult primary neoplasm) * Patients with Mixed NENs (MiNENs) * Patients with poorly differentiated neuroendocrine carcinoma * Pregnancy and breastfeeding

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Conditions

The condition(s) this trial relates to.

digestive system neuroendocrine neoplasm digestive system neuroendocrine tumor, grade 1/2 neuroendocrine neoplasm

As listed by the trial registrant

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

Gep-net Neuroendocrine tumors

How to take part

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

  1. The places running it

    1 site. 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

  • IRCCS OSpedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

More trials for these conditions

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