French Clinical Datbase of Melanoma Patients (RIC-Mel)
ConditionMelanoma (Skin)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with melanoma, of any stage,
Patient agreed to participate.
Disqualifiers
Individuals under court protection
Trial population
Patients with melanoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Overall survival of melanoma patients included in the RIC-Mel database
Overall survival if defined as the time between the primary melanoma tumour removal and the death or the date of data extraction from the RIC-Mel database for alive patients.
Time frame
5 yearsSecondary outcomes
1
Percentage of melanoma patients included in the RIC-Mel database categorized by genders
Distribution of females and males
Time frame
through study completion, an average of 5 years2
Percentage of melanoma patients included in the RIC-Mel database categorized by histological subtypes
Histological subtypes of primary melanoma were categorized as Superficial spreading melanoma, nodular, lentigo maligna melanoma, acral lentiginous melanoma, mucosal, ocular, unknown primary melanoma, and others subtypes. This information is collected from medical records of each patient
Time frame
Day 13
Percentage of melanoma patients included in the RIC-Mel database categorized by breslow thickness
Breslow thickness is defined as the total vertical height of the melanoma, from the very top (called the granular layer) to the area of deepest penetration in the skin. Breslow thickness is the one of the important prognostic factor and it is commonly reported that the higher the Breslow thickness, the worse the prognosis. This information is collected from medical records of each patient. The classifications were lesser than or equal to (≤) 1.0 millimeters (mm), 1.01 - 2.0 mm, 2.01 - 4.0 mm, greater than (\>) 4.0 mm and Unknown.
Time frame
day 14
Percentage of melanoma patients included in the RIC-Mel database categorized by ulceration
Ulceration is defined as an erosion of the first primary tumour, associated with the death of cancer cells in the tumour center. Ulceration is, with breslow thickness, another important prognostic factor. Ulceration is associated with a worth prognostic. This information is collected from medical records of each patient. The classifications were Yes, No and Unknown.
Time frame
day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nantes University Hospital
Lead sponsor
CENGEPS
Collaborator
Bristol-Myers Squibb
Collaborator
Hoffmann-La Roche
Collaborator
GlaxoSmithKline
Collaborator
Amgen
Collaborator
Source ClinicalTrials.gov