Status:
COMPLETED
Study of Molecular Mechanisms Implicated in the Pathogenesis of Melanoma. Role of Exosomes
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Recent progresses have been made in the treatment of metastatic melanoma, nevertheless improved patient survival is still limited because of primary resistance and relapses. It is therefore important ...
Detailed Description
Metastatic melanoma is an aggressive tumor with a 5-year survival rate of about 6 months. Although recent progresses have been made in the treatment of metastatic melanoma, improved patient survival i...
Eligibility Criteria
Inclusion
- Subject of both sexes at least 18 years of age
- Patient with advanced melanoma unresectable (stage IIIc) or metastatic (stage IV)
- Patient for whom is considered a systemic treatment by BRAF inhibitor
- Patient no previously treated or no responding to chemotherapy with a last injection\> 1month
- Patient affected by a melanoma measurable according to version 1.1 of RECIST criteria
- Patient with a life expectancy superior than 3 months
- Serum pregnancy test negative for all women of childbearing age
- ECOG ≤1
- Patient affiliated to French social security
- Patient able to understand and communicate with the investigator and to comply with the requirements of the study
- Patient must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations
Exclusion
- Patients not eligible to a BRAF inhibitor therapy or affected by a serious disease wich could require a treatment susceptible to interfere with melanoma treatment
- Pregnant and lactating women
- Patient with active malignancy or a previous malignancy within the past 3 years; except for patient with resected BCC, resected cutaneous SCC, resected carcinoma in-situ of the cervix, and resected carcinoma in-situ of the breast
- Past medical history record of infection with human immunodeficiency virus or viral hepatite C or B
- Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02310451
Start Date
December 1 2014
End Date
July 31 2023
Last Update
September 8 2023
Active Locations (1)
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1
CHU de Nice ^Hôpital de l'Archet
Nice, France, 06200