Understanding how normal skin cells change to melanoma
Understanding the Transition from Normal Melanocytes to Nevus to Melanoma (NevustoMel)
Fundacion Clinic per a la Recerca Biomédica · NCT06605417
This study is trying to understand how normal skin cells change into melanoma in children and young adults with certain types of moles to help improve early diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Fundacion Clinic per a la Recerca Biomédica (other) |
| Locations | 2 sites (Marseille and 1 other locations) |
| Trial ID | NCT06605417 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the molecular profiles that characterize the transition from benign nevi to malignant melanoma in children and young adults with large congenital melanocytic nevi. It will longitudinally analyze cell-free DNA from participants and utilize advanced techniques such as methylomics and single-cell multi-omics to explore the cellular changes involved in this progression. The study seeks to improve early diagnosis and treatment strategies for intermediate conditions through evidence-based risk assessment and pre-clinical modeling. By integrating various genomic and transcriptomic data, the research aims to provide insights into the molecular mechanisms underlying melanoma development.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with congenital nevi larger than 20 cm.
Not a fit: Patients without available biological material or those who do not provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and treatment options for patients with congenital melanocytic nevi and melanoma.
How similar studies have performed: Other studies utilizing molecular profiling and advanced genomic techniques have shown promise in understanding melanoma progression, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Congenital nevus with estimated size of 20 cm * Be over 18 years of age Exclusion criteria: * No available biological material * Not having signed the informed consent
Where this trial is running
Marseille and 1 other locations
- French National Institute of Health and Medical Research — Marseille, France (RECRUITING)
- Hospital Clínic de Barcelona (Dermatology service) — Barcelona, Spain (RECRUITING)
Study contacts
- Study coordinator: Susana Puig Sardà, MD, PhD
- Email: spuig@clinic.cat
- Phone: +34932275400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Melanocytic Nevi, Melanoma, Skin, Nevi and Melanomas, Congenital melanocytic nevi, Melanoma, Liquid biopsy, cfDNA, Methylomics