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Major study launches to unravel risks of birthmarks

NCT ID NCT06828822

Knowledge-focused Sponsor: Nantes University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 01, 2026 · Updated 2 times

Summary

This study follows 819 children under 2 years old who have medium to giant congenital nevi (pigmented birthmarks). Researchers will track neurological development, melanoma risk, and quality of life over time. The goal is to create better monitoring and treatment guidelines for these children.

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 study could provide clear, evidence-based guidelines for monitoring and treating congenital nevi, reducing anxiety for parents and improving outcomes for children.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test any therapy, and results may take years to influence clinical practice.

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 819 people

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

Started

Jul 2025

Expected to finish

Jul 2031

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

0 years to 24 months

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: * Patient under 2 years old. * Patient with a medium, large, or giant congenital nevus (CN) according to the Krengel classification, either single or multiple. * Patient affiliated with social security. * Patient whose legal representatives consent to their child's participation in the project. Exclusion Criteria: * Patient with light brown spots or pigmented lesions not classified as nevi. * Patient for whom It is impossible to establish annual follow-up. * Patient whose parents do not speak French.

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Conditions

The condition(s) this trial relates to.

large congenital melanocytic nevus melanocytic nevus neurodevelopmental disorder

As listed by the trial registrant

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

Congenital nevus NAEVI Neurodevelopmental disorder

How to take part

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

  1. The places running it

    16 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

  • Angers University Hospital

    RECRUITING

    Angers, Maine et Loire, 49100, France

  • Bordeaux University Hospital

    RECRUITING

    Bordeaux, Gironde, 33000, France

  • Brest University Hospital

    RECRUITING

    Brest, Finistère, 29200, France

  • CHU Lille

    RECRUITING

    Lille, France

  • Dijon University Hospital

    RECRUITING

    Dijon, Côte-d'Or, 21000, France

  • Grasse Hospital

    RECRUITING

    Nice, Alpes-Maritimes, 06130, France

  • La Réunion University Hospital

    RECRUITING

    La Réunion, Département Et Région d'Outre-mer, 97400, France

  • Marseille University Hospital

    RECRUITING

    Marseille, Bouches-du-Rhône, 13005, France

  • Nancy University Hospital

    RECRUITING

    Nancy, Meurthe-et-Moselle, 54000, France

  • Nantes University Hospital

    RECRUITING

    Nantes, Loire Atlantique, 44300, France

  • Nice University Hospital and Lenval Hospital

    RECRUITING

    Nice, Alpes-Maritimes, 06200, France

  • Paris Necker Hospital

    RECRUITING

    Paris, Paris, 75015, France

  • Rennes University Hospital

    RECRUITING

    Rennes, Ille-et-Vilaine, 35000, France

  • Saint Vincent de Paul Hospital

    RECRUITING

    Lille, Nord, 59000, France

  • Toulouse University Hospital

    RECRUITING

    Toulouse, Haute-Garonne, 31300, France

  • Tours University Hospital

    RECRUITING

    Tours, Indre-et-Loire, France

More trials for these conditions

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