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

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

⁃ 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).

Locations
Other Locations
France
CHU d'Amiens
RECRUITING
Amiens
CH Annecy Genevois
RECRUITING
Annecy
CHU de Besançon
RECRUITING
Besançon
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Avicennes
RECRUITING
Bobigny
CHU de Bordeaux Hôpital Haut Levêque
ACTIVE_NOT_RECRUITING
Bordeaux
CHU de Bordeaux Hôpital Saint-André
RECRUITING
Bordeaux
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré
ACTIVE_NOT_RECRUITING
Boulogne-billancourt
CHU de Brest
RECRUITING
Brest
CHU de Caen
ACTIVE_NOT_RECRUITING
Caen
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Henri Mondor
RECRUITING
Créteil
CHU de Dijon
RECRUITING
Dijon
CHU de Grenoble
RECRUITING
Grenoble
CHRU de Lille
RECRUITING
Lille
Centre Léon Bérard
RECRUITING
Lyon
Hospices Civils de Lyon
RECRUITING
Lyon
AP-HM Hopital de la Timone
RECRUITING
Marseille
CHU de Montpellier
RECRUITING
Montpellier
CHU de Nancy
RECRUITING
Nancy
CHU de Nantes
NOT_YET_RECRUITING
Nantes
CHU de Nice
RECRUITING
Nice
CHRU de Nîmes
RECRUITING
Nîmes
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Bichat
RECRUITING
Paris
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Cochin
NOT_YET_RECRUITING
Paris
Assistance Publique - Hôpitaux de Paris (AP-HP), Hopital Saint-Louis, centre d'oncodermatologie
RECRUITING
Paris
CHU de Rennes
ACTIVE_NOT_RECRUITING
Rennes
CLCC Eugène Marquis
ACTIVE_NOT_RECRUITING
Rennes
CHU de Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Celeste Lebbe, MD, PhD
celeste.lebbe@aphp.fr
+33142494679
Backup
Laetitia Da Meda
laetitia.da-meda@aphp.fr
+33142499392
Time Frame
Start Date: 2013-02
Estimated Completion Date: 2026-03
Participants
Target number of participants: 6000
Treatments
Prospective cohort Resectable stage II or III
Patients with resectable stage II or III melanoma
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
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov