French Clinical Datbase of Melanoma Patients (RIC-Mel)

Nantes University Hospital (NUH)

Status

Enrolling

Conditions

Melanoma (Skin)

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT03315468

Prog 09/37-11

Details and patient eligibility

About

With a high incidence, low survival rates and limiter availability of effective treatment, melanoma is one of the research priorities for health authorities. Optimizing the development of both academic and private research requires the availability information on the features of patients.

To meet this need, the French Multidisciplinary Melanoma Group (GMFMel) in collaboration with INCa (French National Cancer Institute), the CeNGEPS (National Centre for Healthcare Products Trial Management) and the CIC-BT0503 from Nantes University Hospital (Biotherapy Clinical Centre of Investigation) has set up in April 2011 a Clinical Investigation Network for melanoma, called the CeNGEPS-GMFMel network. Nowadays, the network is named :

RIC-Mel : network for Research and Clinical Investigation on Melanoma. Aims of the network are to promote translational and epidemiological projects as well as to optimize the achievements of clinical trials.

To achieve these goals, a database was launched in 2012 that gives a permanently updates mapping of melanoma treated in France with the key information needed for any research projects.

Full description

The RIC-Mel network federate clinicians researchers working in clinical and translational research for melanoma and carrying out patients inclusions in the clinical trials. These clinicians are working on clinical cancerology and dermatology sites located throughout the French national territory. Nowadays, the RIC-Mel network consists of 49 centers: 43 public dermatology centers (Hospital centers) and 6 private centers (Cancer centers). The RIC-Mel network is coordinated by Pr B. DRENO (Nantes University Hospital) and Pr C. LEBBE (Saint-Louis Hospital, AP-HP, Paris).

The RIC-Mel database is referred as one of the privileged access to any research program on melanoma by the Cancerology Group of the French Society of Dermatology.

The RIC-Mel database has been approved by French health authorities, both ethically and for confidentiality of data (CCTIRS and CNIL). The database is available on the internet at any given moment thanks to a secure connection. All data are treated confidentially. The active file of patients with melanoma from each participating center is available in the database. All patients agreed to participate may be included in the database, regardless of their stage. Clinical data are collected thanks two forms :

Part I key clinical data for any clinical trial Primary tumour (date of surgery, breslow...), lymph node removal (date, number of invaded lymph node...), AJCC stage, Mutation status, melanoma antigens, melanoma treatments (type, dates) and death.
Part II: additional data for epidemiological and translational research Family history of melanoma, metastases (type, date of diagnosis...), HLA A and B type, additional information on treatments (dose, overall response, grade 3 or 4 side effects with the type, action on treatment and outcome).

In September 2017, more than 20,000 patients with melanoma had been included in the RIC-Mel database, with the following distribution: around 75% of primary stages (0 to II) and 25 % of metastatic stages (III and IV).

Enrollment

16,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria