Multicentric Cohort of Melanoma Patients in Ile de France Area (Melan-Cohort)
This is a multicentric prospective cohort of all stage melanoma patients from AP-HP ,the largest consortium of University hospitals over Europe. 7 investigation sites (7 dermatological services of AP-HP) in Ile de France region are involved. 1200 patients will be enrolled and be followed during 10 years.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Multicentric Cohort of Melanoma Patients in Ile de France Area|
- Overall survival (0-10 years) Disease free survival (0-10 years) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Invasion of sentinel lymph node biopsy [ Time Frame: 2003-2009 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||July 2018 (Final data collection date for primary outcome measure)|
Melan-Cohort should constitute the first multicentric cohort with various objectives: prognostic, therapeutic, cognitive and medico-economical studies on melanoma. Patients will be recruited in all of the dermatology departments of APHP (dermatology departments from AMBROISE PARE, Saint-Louis, BICHAT-Claude Bernard,Henri-Mondor, Cochin-Tarnier, and Tenon hospitals). For all included patients, a standard file is filled comprising all anatomy-clinical useful data and epidemiologic ones, including sun exposures. Blood is harvested to collect DNA, RNA, serum, plasma at inclusion and at regular intervals and in case of progressive disease. Procedures for sentinel lymph node biopsies have been homogenized. An informed consent is obtained for each patient included in the cohort. A steering committee meets on a regular basis, and genetics or pathology subgroups have been constituted. An electronic CRF is available using the Intranet of APHP hospitals. Specimens are stored using high quality standards.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839410
|Pr Philippe Saiag|
|Boulogne Billancourt, Ile de France, France, 92100|
|Principal Investigator:||Philippe Saiag, MD||Assistance Publique - Hôpitaux de Paris|