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

July 7, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Melanoma is on of rare cancer with increasing frequency in France. Prevention can be efficient in detecting melanoma with good prognosis 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 which is highly resistant to conventional treatments. Significant survival benefit was demonstrated since 2011 with anti-CTLA4 +/- anti PD1 antibodies and BRAF and MEK inhibitors.

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.

Study Type

Observational

Enrollment (Estimated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • CHU d'Amiens
        • Contact:
        • Sub-Investigator:
          • Jean-Philippe Arnault, MD
        • Principal Investigator:
          • Gilles Duverlie, MD, PhD
        • Sub-Investigator:
          • Yves-Edouard Herpe, MD
        • Principal Investigator:
          • Catherine Lok, MD, PhD
        • Sub-Investigator:
          • Denis Chatelain, MD
      • Annecy, France
        • Recruiting
        • CH Annecy Genevois
        • Contact:
        • Principal Investigator:
          • Julie De Quatrebarbes, MD, PhD
        • Sub-Investigator:
          • Anne-Claire Bing, MD
        • Sub-Investigator:
          • Laure Bondier, MD
        • Sub-Investigator:
          • Pauline Hoelt, MD
        • Sub-Investigator:
          • Matthieu Levavasseur, MD
      • Besançon, France
        • Recruiting
        • CHU de Besancon
        • Contact:
        • Principal Investigator:
          • François Aubin, MD, PhD
        • Principal Investigator:
          • Severine Valmary-Degano, MD, PhD
        • Sub-Investigator:
          • Charlee Nardin, MD, PhD
      • Bobigny, France, 93000
        • Recruiting
        • Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Avicennes
        • Contact:
        • Principal Investigator:
          • Eve Maubec, MD, PhD
        • Sub-Investigator:
          • Valentine Heidelberger, MD
        • Sub-Investigator:
          • Coralie Zumelzu, MD
        • Sub-Investigator:
          • Beatrice Villette, MD
        • Sub-Investigator:
          • Claudia Bejar, MD
      • Bordeaux, France
        • Active, not recruiting
        • CHU de Bordeaux Hopital Haut leveque
      • Bordeaux, France
        • Recruiting
        • CHU de Bordeaux Hôpital Saint-André
        • Contact:
        • Principal Investigator:
          • Caroline Dutriaux, MD, PhD
        • Sub-Investigator:
          • Sorilla Prey, MD
        • Sub-Investigator:
          • H Conte, MD
        • Sub-Investigator:
          • Emilie Gerard, MD
        • Principal Investigator:
          • Jean-Philippe Merlio, MD, PhD
        • Sub-Investigator:
          • Beatrice Vergier, MD, PhD
        • Sub-Investigator:
          • Pierre Dubus, MD
      • Boulogne-Billancourt, France
        • Active, not recruiting
        • Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré
      • Brest, France
        • Recruiting
        • CHU de Brest
        • Contact:
        • Principal Investigator:
          • Delphine Legoupil, MD
        • Sub-Investigator:
          • Laurent Misery, MD, PhD
        • Sub-Investigator:
          • Claire Abasq, MD
        • Sub-Investigator:
          • Emilie Brenaut, MD
        • Principal Investigator:
          • Pascale Marcorelles, MD, PhD
        • Sub-Investigator:
          • Marie-Cecile Nicot, MD
      • Caen, France
        • Active, not recruiting
        • CHU de Caen
      • Créteil, France, 94000
        • Recruiting
        • Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Henri Mondor
        • Contact:
        • Principal Investigator:
          • Ouidad Zehou, MD, PhD
        • Sub-Investigator:
          • Alice Viarnaud, MD
        • Sub-Investigator:
          • Arnaud Jannic, MD
      • Dijon, France
        • Recruiting
        • CHU de Dijon
        • Contact:
        • Principal Investigator:
          • Sophie Dalac, MD, PhD
        • Sub-Investigator:
          • Geraldine Jeudy, MD
        • Sub-Investigator:
          • Marie-Helene Aubriot Lorton, MD
        • Sub-Investigator:
          • Bertille Bonniaud, MD
        • Principal Investigator:
          • Alain Bonnin, MD, PhD
      • Grenoble, France
        • Recruiting
        • Chu de Grenoble
        • Contact:
        • Principal Investigator:
          • Marie-Therese Leccia, MD, PhD
        • Sub-Investigator:
          • Philippe Lorimier, MD
        • Principal Investigator:
          • Nicole Pinel, MD, PhD
      • Lille, France
        • Recruiting
        • CHRU de Lille
        • Contact:
        • Principal Investigator:
          • Laurent Mortier, MD, PhD
        • Sub-Investigator:
          • Anna Greliak, MD
        • Principal Investigator:
          • Dominique Deplanque, MD, PhD
        • Principal Investigator:
          • Marie-Christine Copin, MD, PhD
        • Sub-Investigator:
          • Philippe Jamme, MD
      • Lyon, France
        • Recruiting
        • Centre Leon Berard
        • Sub-Investigator:
          • Sylvie NEGRIER, MD
        • Contact:
        • Principal Investigator:
          • Mona Amini-Adle, MD, PhD
        • Sub-Investigator:
          • Laura Crumbach, MD
        • Sub-Investigator:
          • Marie-Eve Neidhardt, MD, PhD
      • Lyon, France
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
        • Principal Investigator:
          • Stephane Dalle, MD, PhD
        • Sub-Investigator:
          • Luc Thomas, MD, PhD
        • Principal Investigator:
          • Alexandra Traverse-Glehen, MD, PhD
        • Sub-Investigator:
          • Nicole Fabien, MD
        • Sub-Investigator:
          • Brigitte Balme, MD
        • Sub-Investigator:
          • Lauriane Depaepe, MD
        • Sub-Investigator:
          • Nicolas Poulalhon, MD
        • Sub-Investigator:
          • Marie Perier-Muzet, MD
        • Sub-Investigator:
          • Sebastien Debarbieux, MD
      • Marseille, France
        • Recruiting
        • AP-HM Hopital de la Timone
        • Sub-Investigator:
          • Sandrine Monestier, MD
        • Sub-Investigator:
          • Sylvie Hesse, MD
        • Sub-Investigator:
          • Nausicaa Malissen, MD
        • Principal Investigator:
          • Dominique Figarella-Branger, MD, PhD
        • Contact:
        • Principal Investigator:
          • Caroline Gaudy, MD, MhD
      • Montpellier, France
        • Recruiting
        • CHU de Montpellier
        • Sub-Investigator:
          • Anne-Sophie Bertrand, MD
        • Sub-Investigator:
          • Anouck Lamoureux, MD
        • Principal Investigator:
          • Valerie Costes-Martineau, MD, PhD
        • Sub-Investigator:
          • Anne-Marie Dupuy, MD
        • Sub-Investigator:
          • Valerie Rigau, MD
        • Contact:
      • Nancy, France
        • Recruiting
        • Chu de Nancy
        • Contact:
        • Principal Investigator:
          • Florence Granel-Brocard, MD, PhD
        • Principal Investigator:
          • Jean-Michel Vignaud, MD, PhD
        • Sub-Investigator:
          • E Melgar, MD
        • Sub-Investigator:
          • A Essemilaire, MD
      • Nantes, France
        • Not yet recruiting
        • CHU de Nantes
        • Contact:
        • Principal Investigator:
          • Gaelle Quereux, MD, PhD
      • Nice, France
        • Recruiting
        • CHU de Nice
        • Principal Investigator:
          • Henri MONTAUDIE, MD
        • Sub-Investigator:
          • Thierry Passeron, MD, PhD
        • Sub-Investigator:
          • Florence Le Duff, MD
        • Sub-Investigator:
          • Alexandra Picard, MD
        • Principal Investigator:
          • Paul Hofman, MD, PhD
        • Sub-Investigator:
          • Veronique Hofman, MD
        • Sub-Investigator:
          • Catherine Butori, MD
        • Contact:
        • Sub-Investigator:
          • Jean-Philippe Lacour, MD, PhD
        • Sub-Investigator:
          • Philippe Bahadoran, MD, PhD
        • Sub-Investigator:
          • Laura Troin, MD
      • Nîmes, France
        • Recruiting
        • CHRU de Nîmes
        • Contact:
        • Principal Investigator:
          • Pierre-Emmanuel Stoebner, MD, PhD
        • Sub-Investigator:
          • Fanny Fichel, MD
        • Principal Investigator:
          • Thierry Lavabre-Bertrand, MD, PhD
        • Sub-Investigator:
          • Jean-Baptiste Gaillard, MD
        • Sub-Investigator:
          • Pascal Roger, MD, PhD
      • Paris, France
        • Recruiting
        • Assistance Publique - Hôpitaux de Paris (AP-HP), Hopital Saint-Louis, centre d'oncodermatologie
        • Contact:
        • Sub-Investigator:
          • Barouyr Baroudjian, MD
        • Sub-Investigator:
          • Pauline Laly, MD
        • Sub-Investigator:
          • Julie Delyon, MD, PhD
        • Sub-Investigator:
          • Maxime Batistella, MD
        • Principal Investigator:
          • Celeste Lebbe, MD, PhD
        • Sub-Investigator:
          • Marie-Lea Gauci, MD, PhD
        • Sub-Investigator:
          • Samia Mourah, MD, PhD
      • Paris, France
        • Recruiting
        • Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Bichat
        • Contact:
        • Principal Investigator:
          • Vincent Descamps, MD, PhD
        • Sub-Investigator:
          • Catherine Picard-Dahan, MD, PhD
        • Sub-Investigator:
          • Florence Brunet-Possenti, MD
        • Principal Investigator:
          • Sarah Tubiana, MD
        • Sub-Investigator:
          • Lydia Deschamps, MD
      • Paris, France
        • Not yet recruiting
        • Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Cochin
        • Contact:
        • Principal Investigator:
          • Selim Aractingi, MD, PhD
      • Rennes, France
        • Active, not recruiting
        • CHU de Rennes
      • Rennes, France
        • Active, not recruiting
        • CLCC Eugène Marquis
      • Toulouse, France
        • Recruiting
        • CHU de Toulouse
        • Sub-Investigator:
          • Sophie Thellier, MD
        • Sub-Investigator:
          • Marianne Thomas-Pfaab, MD
        • Sub-Investigator:
          • Cecile Pages Laurent, MD, PhD
        • Principal Investigator:
          • Pierre Brousset, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Florian Deilhes, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

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.

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 10 years
With a Kaplan-Meier curve analysis and Cox model
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 10 years
With a Kaplan-Meier curve analysis and Cox model
10 years
Overall response
Time Frame: 10 years
Determined by tumor assessments
10 years
Nature and incidence of Treatment-Emergent Adverse Events (Safety)
Time Frame: 10 years
Evaluated with CTCAE v4.0 or v5.0
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Director: Brigitte Dreno, MD, PhD, CHU Nantes
  • Study Director: Celeste Lebbe, MD, PhD, AP-HP, Hopital Saint-Louis, centre d'oncodermatologie, Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimated)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID-RCB 2015-A00138-41
  • 2011-244 (Other Grant/Funding Number: National Cancer Institute (INCa))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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