Follow-up of a National Cohort of Melanoma Stage IV and Unresectable Stage III Patients (MelBase)
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|ClinicalTrials.gov Identifier: NCT02828202|
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : February 15, 2019
Prevention of melanoma can be efficient but mortality remains unchanged and 15 to 20% of patients still die from melanoma. Indeed metastatic melanoma is a heterogeneous highly and multiple mutations driven cancer. Significant survival benefit was demonstrated since 2011 with anti-CTLA4, programmed death-1 (anti PD1) antibodies, B-Raf proto-oncogene, serine/threonine kinase (BRAF) and MAP-ERK kinase (MEK) inhibitors. Future improvement of advanced melanoma prognosis will rely on clinico-epidemiological studies and on biological studies aiming to validate and identify new prognostic and predictive factors based upon clinico-epidemiological and histological data, genomic host and tumor alterations, tumor microenvironment characteristics, individual immunological profile and functional imaging. In the context of marketing of costly innovative molecules prospective collection of economic data on treatment and toxicity are required. Large biobanks collecting data from cohorts of advanced melanoma are mandatory for such projects.
MELBASE is a French prospective national cohort enrolling advanced melanoma patients whose objectives are :
- To provide an annual instrument panel with a descriptive and correlative analysis of patients with advanced melanoma in France including epidemiological, clinical and biological socio-economic characteristics
- to validate and identify new clinical, epidemiological, and biological prognostic factors such as genomic host and tumor alterations, tumor microenvironment characteristics, individual immunological profile in advanced melanoma.
- to evaluate the risk-benefit, the impact on treatment on patient quality of life, the management cost of patients treated with the validated and future treatments of metastatic melanoma. The project also aims to define predictive biomarkers of response and toxicity including pharmacogenetics and tumor genetics alterations, tumor microenvironment characteristics, individual immunological profile.
Patients with unresectable stage III or stage IV melanoma will be enrolled prospectively for 1 year with a 5 years follow-up (a total of 2000 patients will be enrolled) from 26 French centers A database of clinical monitoring of metastatic patients will be established and associated with a virtual tumor bank. This national database will be issued from the use of biological, clinical and imaging databases already available in the centers and optimized for this project; this database will also results from the interaction with the French national cancer institute (INCa) genotyping platform.
|Condition or disease||Intervention/treatment|
|Malignant Melanoma||Other: Biological Other: Tissular Other: Quality of life|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Constitution of a National Cohort of Patients With Metastatic Melanoma Stage IV or Unresectable Stage III With the Objective of Setting up a Epidemiological Monitoring and a Clinico-biological Database, MELBASE|
|Actual Study Start Date :||February 2013|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
- Other: Biological
DNA from peripheral blood mononuclear cells, RNA, plasma, serum sampled at inclusion, every 6 months and before each new systemic therapy.
- Other: Tissular
Primary melanoma (mostly paraffin embedded), metastatic sample (s)(paraffin embedded and frozen) from at least 1 site at inclusion and during evolution, particularly before treatment modification if clinically required.
- Other: Quality of life
Specific questionnaires (FACT-M, EUROQUOL) at inclusion, every 3 months and before each new systemic therapy.
- Overall survival [ Time Frame: 5 years ]With a Kaplan-Meier curve analysis and Cox model
- Progression-Free Survival (PFS) [ Time Frame: 5 years ]With a Kaplan-Meier curve analysis and Cox model
- Overall response [ Time Frame: 5 years ]Determined by tumor assessments
- Nature and incidence of Treatment-Emergent Adverse Events (Safety) [ Time Frame: 5 years ]Evaluated with CTCAE v4.0
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828202
|Contact: Celeste Lebbe, MD, PhDfirstname.lastname@example.org|
|Contact: Clara Allayous, PhDemail@example.com|
|Study Director:||Celeste Lebbe, MD, PhD||Assistance Publique - Hôpitaux de Paris (AP-HP), Hopital Saint-Louis, centre d'oncodermatologie, Paris|
|Study Director:||Brigitte Dreno, MD, PhD||CHU Nantes|