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Understanding the Transition from Normal Melanocytes to Nevus to Melanoma

ConditionsCongenital Melanocytic NeviMelanoma, SkinNevi and Melanomas
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFundacion Clinic per a la Recerca Biomédica

About this trial

The primary objective of this study is to identify the molecular identity profiles of all cellular states that characterize the progression from benign nevi to malignant melanoma in CAYA patients with L/GCMN. The secondary objectives are:

* To longitudinally characterize the cell-free DNA (cfDNA) from CAYA patients. * To improve the early diagnosis and treatments for intermediate conditions such as L/GCMN through evidence-based interpretation of personal risk from endogenous or exogenous sources. * To test pre-clinical strategies to best model and improve patient response.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Congenital nevus with estimated size of 20 cm

Be over 18 years of age

Disqualifiers

No available biological material

Not having signed the informed consent

Trial population

Review and/or analysis of pre-existing medical records, biological samples and data collected from patients that have been visited at the different participating hospitals.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Methylomics

    Genetic

    Methylomics analysis of FFPE blocks and frozen tissues

  • RNA sequencing

    Genetic

    RNA sequencing of FFPE blocks and frozen tissues

  • Spatial transcriptomics

    Genetic

    Spatial transcriptomics of FFPE blocks and frozen tissues

  • Liquid biopsy

    Genetic

    cfDNA characterization extracted from blood/saliva

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: L/GCMN4 interventions
Group B: Melanoma4 interventions

Trial outcomes

Primary outcomes

1

Molecular identity profiles

Molecular identity profiles of all cellular states that characterize the progression from benign nevi to malignant melanoma in children, adolescents and young adults (CAYA) patients with large/giant congenital melanocytic nevi (L/GCMN)

Time frame
26 months

Secondary outcomes

1

cfDNA profiles

Longitudinal characterization of the cell-free DNA (cfDNA) of CAYA patients

Time frame
26 months
2

Improve the early diagnosis and treatment of L/GCMN

Improve the early diagnosis and treatments for intermediate conditions such as L/GCMN through evidence-based interpretation of personal risk from endogenous or exogenous sources.

Time frame
26 months
3

Test pre-clinical strategies for L/GCMN

Test pre-clinical strategies to best model and improve patient response with intermediate lesions such as L/GCMN

Time frame
26 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacion Clinic per a la Recerca Biomédica

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator

University Hospital Tuebingen

Collaborator

University of Florence

Collaborator

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborator

University Of Perugia

Collaborator

German Cancer Research Center

Collaborator

Karolinska Institutet

Collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborator

Institut Curie

Collaborator

Medical University of Gdansk

Collaborator

Princess Maxima Center for Pediatric Oncology

Collaborator

Institut Català d'Oncologia

Collaborator

Source ClinicalTrials.gov
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