Actively Recruiting
Follow-up of a National Cohort of Melanoma Resectable Stage II, Stage III or IV Patients or Unresectable Primary
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-02-11
6000
Participants Needed
27
Research Sites
682 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Follow-up of a National Cohort of Melanoma Resectable Stage II, Stage III or IV Patients or Unresectable Primary
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older who consent to participate
- Patients with resectable stage IIA, IIB, IIC, or III melanoma confirmed by histology
- Patients naive to systemic treatment for resectable stage II or III melanoma
- Patients with unresectable primary melanoma or unresectable stage III or stage IV melanoma confirmed by histology
- Patients naive to systemic treatment for unresectable primary or unresectable stage III or IV melanoma, except adjuvant treatment
You will not qualify if you...
- Patients who refuse to participate
- Patients with choroid melanoma
- Patients with resectable stage I melanoma
- Patients with stage IV, unresectable primary, or unresectable stage III melanoma in the resectable cohort
- Patients under guardianship or trusteeship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
CHU d'Amiens
Amiens, France
Actively Recruiting
2
CH Annecy Genevois
Annecy, France
Actively Recruiting
3
CHU de Besançon
Besançon, France
Actively Recruiting
4
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Avicennes
Bobigny, France, 93000
Actively Recruiting
5
CHU de Bordeaux Hôpital Haut Levêque
Bordeaux, France
Active, Not Recruiting
6
CHU de Bordeaux Hôpital Saint-André
Bordeaux, France
Actively Recruiting
7
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré
Boulogne-Billancourt, France
Active, Not Recruiting
8
CHU de Brest
Brest, France
Actively Recruiting
9
CHU de Caen
Caen, France
Active, Not Recruiting
10
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Henri Mondor
Créteil, France, 94000
Actively Recruiting
11
CHU de Dijon
Dijon, France
Actively Recruiting
12
CHU de Grenoble
Grenoble, France
Actively Recruiting
13
CHRU de Lille
Lille, France
Actively Recruiting
14
Centre Léon Bérard
Lyon, France
Actively Recruiting
15
Hospices Civils de Lyon
Lyon, France
Actively Recruiting
16
AP-HM Hopital de la Timone
Marseille, France
Actively Recruiting
17
CHU de Montpellier
Montpellier, France
Actively Recruiting
18
CHU de Nancy
Nancy, France
Actively Recruiting
19
CHU de Nantes
Nantes, France
Not Yet Recruiting
20
CHU de Nice
Nice, France
Actively Recruiting
21
CHRU de Nîmes
Nîmes, France
Actively Recruiting
22
Assistance Publique - Hôpitaux de Paris (AP-HP), Hopital Saint-Louis, centre d'oncodermatologie
Paris, France
Actively Recruiting
23
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Bichat
Paris, France
Actively Recruiting
24
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Cochin
Paris, France
Not Yet Recruiting
25
CHU de Rennes
Rennes, France
Active, Not Recruiting
26
CLCC Eugène Marquis
Rennes, France
Active, Not Recruiting
27
CHU de Toulouse
Toulouse, France
Actively Recruiting
Research Team
C
Celeste Lebbe, MD, PhD
CONTACT
L
Laetitia Da Meda
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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