Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
16000 participants
OBSERVATIONAL
2012-03-01
2030-03-01
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patient agreed to participate.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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CENGEPS
UNKNOWN
Bristol-Myers Squibb
INDUSTRY
Hoffmann-La Roche
INDUSTRY
GlaxoSmithKline
INDUSTRY
Amgen
INDUSTRY
Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Gaëlle Quereux, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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Nantes University Hospital
Nantes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Prog 09/37-11
Identifier Type: -
Identifier Source: org_study_id
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