Ignite Creation Date:
2024-05-06 @ 10:38 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03315468
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2017-10-06
Brief Title:
French Clinical Datbase of Melanoma Patients RIC-Mel
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
French National Cohort of Patients With Melanoma Any Stage Network for Research and Clinical Investigation the RIC-Mel Network
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIC-Mel
Brief Summary:
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
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
Detailed 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 20000 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
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 20000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None