Actively Recruiting

Age: 18Years +
All Genders
NCT02828202

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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