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

NCT02828202 | Recruiting DMC

• 2 other identifiers: ID-RCB 2015-A00138-412011-244
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 27

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.

Conditions

Malignant Melanoma

Keywords

Melanoma; Skin; Biobank

Outcome Measures

Primary Outcomes (1)

• Overall survival

  With a Kaplan-Meier curve analysis and Cox model

  10 years

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  10 years

• Overall response

  10 years

• Nature and incidence of Treatment-Emergent Adverse Events (Safety)

  10 years

Study Arms (2)

Prospective cohort Resectable stage II or III

Patients with resectable stage II or III melanoma

Other: Biological; Other: Tissular; Other: Quality of life

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; Other: Tissular; Other: Quality of life

Interventions

Biological OTHER

DNA from peripheral blood mononuclear cells, RNA, plasma, serum sampled at inclusion, every 6 months and before each new systemic therapy.

Prospective cohort Resectable stage II or III; Prospective cohort Unresectable stage III or stage IV (resectable or not) or unresectable primary

Tissular OTHER

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.

Prospective cohort Resectable stage II or III; Prospective cohort Unresectable stage III or stage IV (resectable or not) or unresectable primary

Quality of life OTHER

Specific questionnaires (FACT-M, EUROQUOL) at inclusion, every 3 months and before each new systemic therapy.

Prospective cohort Resectable stage II or III; Prospective cohort Unresectable stage III or stage IV (resectable or not) or unresectable primary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Patients refusal. Choroid melanoma. Resectable stage 1 melanoma. Stage 4, unresectable primitive or unresectable stage 3 melanoma. Patients under guardianship and under trusteeship.
• Cohort patients with Unresectable stage III or stage IV (resectable or not) or unresectable primary:
• 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).
• Resectable stage 1, 2 or 3 melanoma. Patients refusal. Choroid melanoma. Patients under guardianship and under trusteeship.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• National Cancer Institute (NCI): collaborator

Study Sites (27)

CHU d'Amiens

Amiens, France

RECRUITING

CH Annecy Genevois

Annecy, France

RECRUITING

CHU de Besançon

Besançon, France

RECRUITING

Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Avicennes

Bobigny, 93000, France

RECRUITING

CHU de Bordeaux Hôpital Haut Levêque

Bordeaux, France

ACTIVE NOT RECRUITING

CHU de Bordeaux Hôpital Saint-André

Bordeaux, France

RECRUITING

Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré

Boulogne-Billancourt, France

ACTIVE NOT RECRUITING

CHU de Brest

Brest, France

RECRUITING

CHU de Caen

Caen, France

ACTIVE NOT RECRUITING

Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Henri Mondor

Créteil, 94000, France

RECRUITING

CHU de Dijon

Dijon, France

RECRUITING

CHU de Grenoble

Grenoble, France

RECRUITING

CHRU de Lille

Lille, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Hospices Civils de Lyon

Lyon, France

RECRUITING

AP-HM Hopital de la Timone

Marseille, France

RECRUITING

CHU de Montpellier

Montpellier, France

RECRUITING

CHU de Nancy

Nancy, France

RECRUITING

CHU de Nantes

Nantes, France

NOT YET RECRUITING

CHU de Nice

Nice, France

RECRUITING

CHRU de Nîmes

Nîmes, France

RECRUITING

Assistance Publique - Hôpitaux de Paris (AP-HP), Hopital Saint-Louis, centre d'oncodermatologie

Paris, France

RECRUITING

Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Bichat

Paris, France

RECRUITING

Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Cochin

Paris, France

NOT YET RECRUITING

CHU de Rennes

Rennes, France

ACTIVE NOT RECRUITING

CLCC Eugène Marquis

Rennes, France

ACTIVE NOT RECRUITING

CHU de Toulouse

Toulouse, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 35288462 DERIVED

Related Links

• 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

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.

MeSH Terms

Conditions

Melanoma

Interventions

Biological Products; Quality of Life

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Celeste Lebbe, MD, PhD

  AP-HP, Hopital Saint-Louis, centre d'oncodermatologie, Paris

  STUDY DIRECTOR

• Gaelle Quereux, MD, PhD

  Nantes University Hospital

  STUDY DIRECTOR

Central Study Contacts

Celeste Lebbe, MD, PhD

CONTACT

+33142494679; celeste.lebbe@aphp.fr

Laetitia Da Meda

CONTACT

+33142499392; laetitia.da-meda@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: July 11, 2016
• Study Start: February 1, 2013
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (27)