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Trial Title:
Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients
NCT ID:
NCT06281912
Condition:
Early Melanoma
Advanced Melanoma
Conditions: Official terms:
Melanoma
Conditions: Keywords:
PD-1 antibodies, childhood, adolescent, melanoma
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Summary:
This is a retrospective observational cohort study, the primary objective is investigate
the activity and efficacy of anti PD-1 antibodies in children, adolescents and young
adult melanoma patients, with radically resected or metastatic disease
Detailed description:
The aim of the study is to evaluate the activity and efficacy of anti PD-1 antibodies in
adolescent, childhood and young adult with early and advanced melanomas through a
multicenter transnational European retrospective analysis Clinical outcomes will be
retrospectively retrieved beginning from the primary diagnosis of melanoma. Clinical
outcomes will be retrospectively evaluated starting from the time of start of treatment
for up to a the most recent follow-up. Data collected will include demographic
information, disease history, baseline conditions, clinical outcomes of interest.
Criteria for eligibility:
Study pop:
Adolescent, childhood and young adult with early and advanced melanomas treated with anti
PD-1 therapy
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Patients of either sex aged ≥ 12 years;
2. Histologically confirmed melanoma;
3. Anti PD-1 Immunotherapy (Ipilimumab plus Nivolumab);
4. Previous and subsequent treatments will be collected;
5. Clinical and follow-up data available
Exclusion Criteria:
1. No immunotherapy received;
2. No melanoma;
3. Age > 30 yrs
Gender:
All
Minimum age:
12 Years
Maximum age:
30 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Aix-Marseille Universite
Address:
City:
Marseille
Country:
France
Facility:
Name:
Institut Curie
Address:
City:
Paris
Country:
France
Facility:
Name:
Ospedale universitario della Charité
Address:
City:
Berlino
Country:
Germany
Facility:
Name:
German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ)
Address:
City:
Heidelberg
Country:
Germany
Facility:
Name:
University Children's Hospital Tuebingen
Address:
City:
Tuebingen
Country:
Germany
Facility:
Name:
Universita Degli Studi Di Firenze
Address:
City:
Firenze
Country:
Italy
Facility:
Name:
Fondazione Irccs Istituto Nazionale Dei Tumori
Address:
City:
Milano
Country:
Italy
Facility:
Name:
Universita Cattolica Del Sacro Cuore
Address:
City:
Roma
Country:
Italy
Facility:
Name:
Princess Máxima Center for Pediatric Oncology (Prinses Máxima Centrum voor kinderoncologie)
Address:
City:
Utrecht
Country:
Netherlands
Facility:
Name:
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Address:
City:
Warsaw
Country:
Poland
Facility:
Name:
Institut Catala D'Oncologia
Address:
City:
Barcellona
Country:
Spain
Facility:
Name:
Instituto de Investigaciones Biomédicas August Pi i Sunyer
Address:
City:
Barcellona
Country:
Spain
Facility:
Name:
Karolinska University Hospital
Address:
City:
Stockholm
Country:
Sweden
Start date:
March 2024
Completion date:
November 2024
Lead sponsor:
Agency:
Azienda Ospedaliera di Perugia
Agency class:
Other
Source:
Azienda Ospedaliera di Perugia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06281912
