Status:
UNKNOWN
A Prospective Observational Study on Targeted Therapy for Unresectable or Metastatic BRAFV600E Mutant Melanoma Patients
Lead Sponsor:
Pierre Fabre Medicament
Conditions:
Melanoma (Skin)
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Brief Summary
1. Background The purpose of this study is to describe the profile of patients with BRAF-mutated melanoma treated with BRAF/MEK inhibitors combination and using the Tavie Skin application. TavieSk...
Detailed Description
1. BACKGROUND AND RATIONALE 1.1 BACKGROUND Melanoma: overview of disease and management options Melanoma is one of the most aggressive cancers and is responsible for the majority of skin cance...
Eligibility Criteria
Inclusion
- Only patients starting to use the TavieSkin app will be eligible for enrollment in the survey.
- The patient should meet all the following inclusion criteria to be eligible for participating:
- Male or female aged ≥18 years at diagnosis of unresectable or metastatic melanoma;
- Diagnosis of histologically or cytologically confirmed BRAF-mutant melanoma that is metastatic or unresectable, documented as per routine practice
- Patient having an ongoing prescription of one of the three commercially available BRAFi/MEKi combination therapy, at any line of treatment
- Patient using the TavieSkin app and having signed an informed consent (e-consent via the app) for data collection , according to local regulations
Exclusion
- Patients will be excluded from the survey if they fulfil any of the following criteria:
- Patients with other BRAFi/MEKi combination than those available on the market
- Patient receiving a BRAFi/MEKi combination in the adjuvant setting
- Patients under guardianship because of mental illness or any other reason
- Patients treated with a treatment that is not licensed for local use (including approved BRAFi/MEKi combination associated with another product)
Key Trial Info
Start Date :
February 2 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04911998
Start Date
February 2 2021
End Date
December 1 2024
Last Update
June 2 2022
Active Locations (1)
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1
Hospital Evora
Evora, Portugal