Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
819 participants
INTERVENTIONAL
2025-06-01
2031-06-01
Brief Summary
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A large CN can lead to several clinical issues, including:
Risk of neurological disorders: Large CN can be associated with neurological abnormalities such as neuro-meningeal melanosis, hydrocephalus, or brain malformations. These conditions may cause early neuro-developmental delays. The risk is not well understood and requires further studies.
Risk of melanoma: The risk of developing melanoma is higher for a large CN but remains low for smaller ones. Increased monitoring is necessary during the early years for large and giant CN.
Psycho-social impact: Parents often experience significant anxiety at birth due to the cancer risk and social stigma. As the child grows, a visible CN may impact their quality of life, particularly socially at school.
Management of CN remains controversial, especially for those of medium to giant size or with multiple satellites. There is an urgent need for further research to clarify best practices in monitoring and treatment, including the need for routine brain imaging and criteria for surgical intervention.
Ultimately, this study aims to deepen our understanding of CN, its associated neurological and melanoma risks, and the psycho-social challenges it poses, while striving to establish clear, evidence-based guidelines for monitoring and treatment to enhance patient outcomes and quality of life.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Child with a congenital nevus
Neurodevelopmental assessment
This assessment will be conducted using the ASQ-3 test. (ASQ-3 stands for Ages and Stages Questionnaires, Third Edition, which is a common screening tool for evaluating developmental progress in young children.)
Patient quality of life assessment
Collection of patient quality of life data
Legal representatives
Meeting with the parents
This meeting will evaluate the parents' acceptance of the lesion and their quality of life using the MARKS test (Measure of Acceptance of Skin Marks). The results will provide insights into how the parents perceive the lesion and how it impacts their daily lives.
Interventions
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Neurodevelopmental assessment
This assessment will be conducted using the ASQ-3 test. (ASQ-3 stands for Ages and Stages Questionnaires, Third Edition, which is a common screening tool for evaluating developmental progress in young children.)
Meeting with the parents
This meeting will evaluate the parents' acceptance of the lesion and their quality of life using the MARKS test (Measure of Acceptance of Skin Marks). The results will provide insights into how the parents perceive the lesion and how it impacts their daily lives.
Patient quality of life assessment
Collection of patient quality of life data
Eligibility Criteria
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Inclusion Criteria
* 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 for whom It is impossible to establish annual follow-up.
* Patient whose parents do not speak French.
0 Years
24 Months
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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Grasse Hospital
Nice, Alpes-Maritimes, France
Nice University Hospital and Lenval Hospital
Nice, Alpes-Maritimes, France
Marseille University Hospital
Marseille, Bouches-du-Rhône, France
Dijon University Hospital
Dijon, Côte-d'Or, France
La Réunion University Hospital
La Réunion, Département Et Région D'outre-mer, France
Brest University Hospital
Brest, Finistère, France
Bordeaux University Hospital
Bordeaux, Gironde, France
Toulouse University Hospital
Toulouse, Haute-Garonne, France
Rennes University Hospital
Rennes, Ille-et-Vilaine, France
Tours University Hospital
Tours, Indre-et-Loire, France
Nantes University Hospital
Nantes, Loire Atlantique, France
Angers University Hospital
Angers, Maine et Loire, France
Nancy University Hospital
Nancy, Meurthe-et-Moselle, France
Saint Vincent de Paul Hospital
Lille, Nord, France
Paris Necker Hospital
Paris, Paris, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC24_0532
Identifier Type: -
Identifier Source: org_study_id
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