Follow-up of a National Cohort of Melanoma Resectable Stage II, Stage III or IV Patients or Unresectable Primary
NCT ID: NCT02828202
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6000 participants
OBSERVATIONAL
2013-02-28
2026-03-31
Brief Summary
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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.
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Detailed Description
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In 2019, melanoma treatment with anti-PD1 antibodies or BRAFi+MEKi (dabrafenib+trametinib) was approved in stage III patients. Since 2023, in France, pembrolizumab is also approved for stage IIB/IIC melanoma patients ; thus, adjuvant therapy will be generalized without any sentinel lymph node surgery.
In addition, patients could also be treated by neoadjuvant therapies (pembrolizumab or clinical trial) in case of macroscopique stage III, pauci-metastatic stage IV or in case of rare stage II without surgery.
Future improvement of advanced melanoma prognosis will rely on clinico-epidemiological or biological studies to validate and identify new prognostic and predictive factors, also based on 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, an assessment of resource consumption is required, with prospective collection of economic data on treatment and toxicity. Large biobanks collecting data from cohorts of advanced melanoma are mandatory for such projects.
Thus, MELBASE is a French national clinical biobank 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. If possible, cost-effectiveness ratios will be calculated either in all treated patients or in selected populations of patients (based on clinical or biological criteria, like biomarkers), in order to identify populations where these new therapeutics will be the most cost-effective.
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.
The information collected in MELBASE will include clinical constitutional factors, factors linked to primary melanoma, factors linked to previous lymph node involvement, tumor kinetics informations, "American Joint Committee on Cancer" (AJCC) stage at inclusion and after various therapeutic intervention, serological markers, metastatic tumor genotyping (one or more sites, one or more time points), therapeutic interventions (medical, surgical, radiotherapy and palliative strategies) with evaluation of response, tolerance, medical direct costs, impact on quality of life,informations on COVID-19 infection and vaccination, consequences on melanoma treatment, date of death, date of latest news.
A virtual Tumor bank collecting samples (optional) mentions available samples stored each participating centers' Biological Resource Centers (BRC) : 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 from peripheral blood mononuclear cells, plasma/serum sampled at inclusion, every 6 months and at each new treatment line during 3 years.
All date will be collected and organized on a data warehouse to generate clinico-epidemiological reports, analysis and a virtual catalog of biological material.
MELBASE project is consistent with the ethical chart of the hospital tumor banks published by the national French Cancer Institute (INCa). MelBase will also be managed by a chart ensuring each participating center management autonomy and availability of collected data A multidisciplinary scientific advisory board will identify research priorities based on clinical practice and scientific knowledge.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prospective cohort Resectable stage II or III
Patients with resectable stage II or III melanoma
Biological
DNA from peripheral blood mononuclear cells, RNA, plasma, serum sampled at inclusion, every 6 months and before each new systemic therapy.
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.
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
Biological
DNA from peripheral blood mononuclear cells, RNA, plasma, serum sampled at inclusion, every 6 months and before each new systemic therapy.
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.
Quality of life
Specific questionnaires (FACT-M, EUROQUOL) at inclusion, every 3 months and before each new systemic therapy.
Interventions
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Biological
DNA from peripheral blood mononuclear cells, RNA, plasma, serum sampled at inclusion, every 6 months and before each new systemic therapy.
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.
Quality of life
Specific questionnaires (FACT-M, EUROQUOL) at inclusion, every 3 months and before each new systemic therapy.
Eligibility Criteria
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Inclusion Criteria
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).
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
2. Cohort patients with Unresectable stage III or stage IV (resectable or not) or unresectable primary:
Resectable stage 1, 2 or 3 melanoma. Patients refusal. Choroid melanoma. Patients under guardianship and under trusteeship.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Celeste Lebbe, MD, PhD
Role: STUDY_DIRECTOR
AP-HP, Hopital Saint-Louis, centre d'oncodermatologie, Paris
Gaelle Quereux, MD, PhD
Role: STUDY_DIRECTOR
Nantes University Hospital
Locations
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CHU d'Amiens
Amiens, , France
CH Annecy Genevois
Annecy, , France
CHU de Besançon
Besançon, , France
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Avicennes
Bobigny, , France
CHU de Bordeaux Hôpital Haut Levêque
Bordeaux, , France
CHU de Bordeaux Hôpital Saint-André
Bordeaux, , France
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré
Boulogne-Billancourt, , France
CHU de Brest
Brest, , France
CHU de Caen
Caen, , France
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Henri Mondor
Créteil, , France
CHU de Dijon
Dijon, , France
CHU de Grenoble
Grenoble, , France
CHRU de Lille
Lille, , France
Centre Léon Bérard
Lyon, , France
Hospices Civils de Lyon
Lyon, , France
AP-HM Hopital de la Timone
Marseille, , France
CHU de Montpellier
Montpellier, , France
CHU de Nancy
Nancy, , France
CHU de Nantes
Nantes, , France
CHU de Nice
Nice, , France
CHRU de Nîmes
Nîmes, , France
Assistance Publique - Hôpitaux de Paris (AP-HP), Hopital Saint-Louis, centre d'oncodermatologie
Paris, , France
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Bichat
Paris, , France
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Cochin
Paris, , France
CHU de Rennes
Rennes, , France
CLCC Eugène Marquis
Rennes, , France
CHU de Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Plaschka M, Benboubker V, Grimont M, Berthet J, Tonon L, Lopez J, Le-Bouar M, Balme B, Tondeur G, de la Fouchardiere A, Larue L, Puisieux A, Grinberg-Bleyer Y, Bendriss-Vermare N, Dubois B, Caux C, Dalle S, Caramel J. ZEB1 transcription factor promotes immune escape in melanoma. J Immunother Cancer. 2022 Mar;10(3):e003484. doi: 10.1136/jitc-2021-003484.
Related Links
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Di Filippo Y. et al., Relevance of body mass index as a predictor of systemic therapy outcomes in metastatic melanoma: analysis of the MelBase French cohort data; Ann Oncol . 2021 Apr;32(4):542-551. doi: 10.1016/j.annonc.2020.12.012.
Kandel M. et al., Update of survival and cost of metastatic melanoma with new drugs: Estimations from the MelBase cohort ; Eur J Cancer . 2018 Dec;105:33-40. doi: 10.1016/j.ejca.2018.09.026.
Vallet A. et al., Association of Time From Primary Diagnosis to First Distant Relapse of Metastatic Melanoma With Progression of Disease and Survival ; JAMA Dermatol . 2019 Jun 1;155(6):673-678. doi: 10.1001/jamadermatol.2019.0425.
Tetu et al.Impact of radiotherapy administered simultaneously with systemic treatment in patients with melanoma brain metastases within MelBase, a French multicentric prospective cohort; Eur J Cancer 2019 May;112:38-46
Kandel M et al., Quality-of-life assessment in French patients with metastatic melanoma in real life; Cancer . 2020 Feb 1;126(3):611-618. doi: 10.1002/cncr.32554.
Huynh S. et al., Combined Therapy with Anti-PD1 and BRAF and/or MEK Inhibitor for Advanced Melanoma: A Multicenter Cohort Study; Cancers (Basel) . 2020 Jun 23;12(6):1666. doi: 10.3390/cancers12061666
Carlet C. et al., Late-onset adverse events of anti-PD1 therapy in melanoma patients: An observational study from MELBASE, a nationwide prospective cohort; J Am Acad Dermatol . 2022 Feb;86(2):345-352. doi: 10.1016/j.jaad.2021.06.849
Casarotto E. et al., Real-world effectiveness of pembrolizumab in advanced melanoma: analysis of a French national clinicobiological database ; Immunotherapy . 2021 Aug;13(11):905-916. doi: 10.2217/imt-2021-0077
Becquart O. et al., Tolerance and Effectiveness of Targeted Therapies in Aged Patients with Metastatic Melanoma ; Cancers (Basel) . 2021 Jun 18;13(12):3042. doi: 10.3390/cancers13123042.
Girod M. et al., Non-V600E/K BRAF Mutations in Metastatic Melanoma: Molecular Description, Frequency, and Effectiveness of Targeted Therapy in a Large National Cohort ; JCO Precis Oncol . 2022 Nov;6:e2200075. doi: 10.1200/PO.22.00075.
Placais L. et al.,Risk of irAEs in patients with autoimmune diseases treated by immune checkpoint inhibitors for stage III or IV melanoma: results from a matched case-control study; Ann Rheum Dis 2022 Oct;81(10):1445-1452. doi: 10.1136/ard-2022-222186
Rousset P. et al., Impact of systemic therapies in metastatic melanoma of unknown primary: A study from MELBASE, a French multicentric prospective cohort; J Am Acad Dermatol . 2023 Apr;88(4):808-815. doi: 10.1016/j.jaad.2022.11.040
Kandel M. et al., Cost-Effectiveness Analysis of Sequential Treatment Strategies for Advanced Melanoma in Real Life in France
Russo D. et al., Differential gradients of immunotherapy vs targeted therapy efficacy according to the sun-exposure pattern of the site of occurrence of primary melanoma: a multicenter prospective cohort study (MelBase)
Fournier M. et al., Hyperprogression in advanced melanoma is not restricted to immunotherapy
Macaire C. et al., Real-life effectiveness on overall survival of continued immune checkpoint inhibition following progression in advanced melanoma: estimation from the Melbase cohort
Amiot M. et al., When to stop immunotherapy for advanced melanoma: the emulated target trials
Billard K. et al., The efficacy and safety of first-line metastatic melanoma treatment with ipilimumab + nivolumab versus nivolumab in a real-world setting
Campo Le Brun I. et al., Methods of nivolumab administration in advanced melanoma: A comparison of patients' clinical outcomes treated with flat dose or weight-adjusted dose, a multicenter observational study
Other Identifiers
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2011-244
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ID-RCB 2015-A00138-41
Identifier Type: -
Identifier Source: org_study_id
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