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Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients

NCT ID: NCT06281912

Last Updated: 2024-02-28

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-31

Study Completion Date

2024-11-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Early Melanoma Advanced Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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adolescent/childhood

patients \<20 years old with with stage III and IV melanoma diagnosis

No interventions assigned to this group

young adult

patients \< 30 years with stage III and IV melanoma diagnosis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera di Perugia

OTHER

Sponsor Role lead

Responsible Party

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Mario Mandalà

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aix-Marseille Universite

Marseille, , France

Site Status

Institut Curie

Paris, , France

Site Status

Ospedale universitario della Charité

Berlin, , Germany

Site Status

German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ)

Heidelberg, , Germany

Site Status

University Children's Hospital Tuebingen

Tübingen, , Germany

Site Status

Universita Degli Studi Di Firenze

Florence, , Italy

Site Status

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, , Italy

Site Status

Universita Cattolica Del Sacro Cuore

Roma, , Italy

Site Status

Princess Máxima Center for Pediatric Oncology (Prinses Máxima Centrum voor kinderoncologie)

Utrecht, , Netherlands

Site Status

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Warsaw, , Poland

Site Status

Institut Catala D'Oncologia

Barcelona, , Spain

Site Status

Instituto de Investigaciones Biomédicas August Pi i Sunyer

Barcelona, , Spain

Site Status

Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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France Germany Italy Netherlands Poland Spain Sweden

Central Contacts

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Mario Mandala, MD

Role: CONTACT

[email protected]
00393386605619

Roberta Matocci

Role: CONTACT

[email protected]
+390755784099

Other Identifiers

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4504/23

Identifier Type: -

Identifier Source: org_study_id

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