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New study hopes to spot cancer early in NF1 patients

NCT ID NCT06222203

Knowledge-focused Sponsor: National Cancer Institute (NCI) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 5 times

Summary

This study is for people aged 3 and older with neurofibromatosis type 1 (NF1), a genetic condition that often causes noncancerous nerve tumors. About half of people with NF1 get these tumors, and sometimes they turn cancerous. Researchers want to test a new method to predict which tumors might become cancer. Participants will have blood tests, scans, and physical exams, and will be followed for up to 10 years to see how well the prediction method works.

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 225 people

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

Started

Oct 2024

Expected to finish

Dec 2035

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants aged \>= 3 years old with a clinical or genetic diagnosis of NF1; parents or guardians of participants ages 8-17 years old.

Ages

3 to 120 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: High-Risk and Low-Risk NF1 Cohorts * Age \>= 3 years old * Participants with clinical or genetic diagnosis of NF1. * Participants with a diagnosis of mosaic or segmental NF1 are also eligible. * Individuals may have (High-Risk Cohort) or not have (Low-Risk Cohort) at least one of the following characteristics: * Microdeletion or 844-848 missense variants or other variants associated with increased risk of malignant peripheral nervous sheath tumor (MPNST) * Family history of MPNST / atypical neurofibromatous neoplasm of unknown biologic potential (ANNUBP) / atypical neurofibromas (ANF) * Personal history of MPNST/ANNUBP/ANF or neurofibroma with CDKN2A/B loss * Prior radiation therapy at any site * Large plexiform neurofibroma (PN) burden (\>= 350 mL) * Presence \>= 1 DNL at baseline * The ability of the individual, parent/guardian or Legally Authorized Representative (LAR) to understand and the willingness to sign a written consent document for participation. EXCLUSION CRITERIA: High-Risk and Low-Risk NF1 Cohorts \- Inability or unwillingness to undergo MRI imaging INCLUSION CRITERIA: Parent Cohort * Parent or guardian of pediatric individuals (8-17 years old) in High-Risk or Low-Risk Cohorts. * The ability of the parent/guardian or LAR to understand and the willingness to sign a written consent document for parent/guardian participation in this study. EXCLUSION CRITERIA: Parent Cohort \- None.

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Conditions

The condition(s) this trial relates to.

nerve sheath neoplasm neurofibroma neurofibromatosis type 1 neurofibrosarcoma plexiform neurofibroma

As listed by the trial registrant

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

Nerve sheath neoplasms Neurofibromatosis 1

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

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

More trials for these conditions

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