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Follow-up of a National Cohort of Melanoma Resectable Stage II, Stage III or IV Patients or Unresectable Primary (MelBase)

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ClinicalTrials.gov Identifier: NCT02828202
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : July 10, 2023
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 to validate and identify new prognostic and predictive factors based on 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 descriptive and correlative analysis of advanced melanoma patients in France including epidemiological, clinical, biological and economic characteristics
  • 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
  • evaluate the risk-benefit, quality of life, the management cost of patients treated with validated and future treatments. 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 resectable stage II or III will be enrolled since June 2023 with a 10 years follow-up.

Patients with unresectable stage III or IV (resectable or not) or unresectable primary melanoma will be enrolled prospectively since March 2013 with a 10 years follow-up (up to 6000 patients) from 27 French centers.


Condition or disease Intervention/treatment
Malignant Melanoma Other: Biological Other: Tissular Other: Quality of life

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Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Constitution of a National Cohort of Patients With Metastatic Melanoma Resectable Stage II or Stage III or IV or Unresectable Primary With the Objective of Setting up Epidemiological Monitoring and Clinico-biological Database, MELBASE
Actual Study Start Date : February 2013
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Group/Cohort Intervention/treatment
Prospective cohort Resectable stage II or III
Patients with resectable stage II or III melanoma
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.

Prospective cohort Unresectable stage III or stage IV (resectable or not) or unresectable primary
Patients with unresectable stage III, or stage IV (resectable or not) or unresectable primary melanoma
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: 10 years ]
    With a Kaplan-Meier curve analysis and Cox model


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 10 years ]
    With a Kaplan-Meier curve analysis and Cox model

  2. Overall response [ Time Frame: 10 years ]
    Determined by tumor assessments

  3. Nature and incidence of Treatment-Emergent Adverse Events (Safety) [ Time Frame: 10 years ]
    Evaluated with CTCAE v4.0 or v5.0


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
  1. Cohort Patients with Resectable stage II or III melanoma.
  2. Cohort Patients With Metastatic Melanoma Stage IV (resectable or not) or Unresectable Stage III or unresectable primary.
Criteria
  1. Cohort Patients with Resectable stage II or III

    Inclusion Criteria:

    Patients diagnosed with resectable stage IIA/IIB/IIC or III melanoma, confirmed by histological exam.

    Naïve of systemic treatment for resectable stage II or III. Whose metastatic tumoral material can be collected by the Biological Resource Centers (optional criteria).

    Aged ≥ 18 years. Consenting to participate (signed informed consent).

    Exclusion Criteria:

    Patients refusal. Choroid melanoma. Resectable stage 1 melanoma. Stage 4, unresectable primitive or unresectable stage 3 melanoma. Patients under guardianship and under trusteeship.

  2. Cohort patients with Unresectable stage III or stage IV (resectable or not) or unresectable primary:

Inclusion Criteria:

Patients diagnosed with an advanced melanoma, confirmed by histological exam. Unresectable primitive or unresectable stage III or stage IV (resectable or not) melanoma ; or patients treated by neoadjuvant treatment (exceptional) Naïve of systemic treatment for unresectable primitive or unresectable stage III or stage IV (resectable or not) melanoma, except adjuvant treatment.

Whose metastatic tumoral material can be collected by the Biological Resource Centers (optional criteria).

Aged ≥ 18 years. Consenting to participate (signed informed consent).

Exclusion Criteria:

Resectable stage 1, 2 or 3 melanoma. Patients refusal. Choroid 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 AP-HP, Hopital Saint-Louis, centre d'oncodermatologie, Paris
Study Director: Brigitte Dreno, MD, PhD Nantes University Hospital
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: National Cancer Institute (INCa) )
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 10, 2023
Last Verified: March 2023
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
Skin Neoplasms
Neoplasms by Site
Skin Diseases