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Trial record 1 of 1 for:    MELBASE
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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    With a Kaplan-Meier curve analysis and Cox model


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 5 years ]
    With a Kaplan-Meier curve analysis and Cox model

  2. Overall response [ Time Frame: 5 years ]
    Determined by tumor assessments

  3. Nature and incidence of Treatment-Emergent Adverse Events (Safety) [ Time Frame: 5 years ]
    Evaluated with CTCAE v4.0


Biospecimen Retention:   Samples With DNA
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, DNA and RNA from peripheral blood mononuclear cells, plasma, serum, peripheral blood mononuclear cells sampled at inclusion, every 6 months and before each new systemic therapy during 3 years.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With Metastatic Melanoma Stage IV or Unresectable Stage III.
Criteria

Inclusion Criteria:

  • Patients diagnosed with an advanced melanoma, confirmed by histological exam.
  • Primitive unresectable stage 3 or 4 melanoma.
  • Aged > 18 years.
  • Naïve of systemic treatment for an unresectable stage 3 or 4 melanoma, except adjuvant treatment.
  • Whose metastatic tumoral material can be collected by the Biological Resource Centers (optional criteria).
  • Consenting to participate (signed informed consent).

Exclusion Criteria:

  • Patients refusal.
  • Choroid melanoma.
  • Resectable stage 1, 2 or 3 melanoma.
  • Patients under guardianship and under trusteeship.

Information from the National Library of Medicine

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


Contacts
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Contact: Celeste Lebbe, MD, PhD +33142494679 celeste.lebbe@aphp.fr
Contact: Clara Allayous, PhD +33142499392 clara.allayous@aphp.fr

Locations
Show Show 27 study locations
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Cancer Institute (NCI)
Investigators
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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
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02828202    
Other Study ID Numbers: ID-RCB 2015-A00138-41
2011-244 ( Other Grant/Funding Number: INCa )
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Melanoma
Skin
Biobank
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas