Clinical trial NCT00839410: Multicentric Cohort of Melanoma Patients in Ile de France Area
Official title: Multicentric Cohort of Melanoma Patients in Ile de France Area
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Genetic Polymorphism
Keywords: skin cancer
melanoma
sentinel lymph node biopsy
bio bank
genetic polymorphism
prospective cohort
cohort
sentinel lymph nodes
tissue samples
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-02-09
Enrollment: 1255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with anatomo-pathologically proved melanoma

Brief summary: 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. 1300 patients will be enrolled and be followed during 10 years.

Detailed description: 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.

Eligibility criteria: Inclusion criteria :

* age ≥ 18 years
* an informed consent is obtained
* patients with anatomy-pathologically proved melanoma
* the tissue sample of melanoma is available
* the primary melanoma is treated according to the international standard
* absence of a progressive non neoplastic pathology involving life-threatening
* patient living in Ile de France region.
* time limit to entry in the cohort must be:
* within 3 months after Surgical resumption of primary melanoma;
* within 3 months after curative surgical treatment;
* with one month after diagnosis of a transit metastasis or a distant metastasis.

Exclusion criteria :

* refusal of the patient
* pathology sample isn't available
* primary melanoma not being treated according to the international standard
* patient living too far to follow regular visits
* patient diagnosed with a progressive non neoplastic pathology involving life-threatening
* too late to entry and lack of useful stored specimens to research.

Primary outcomes:
measure: Overall survival (0-10 years) Disease free survival (0-10 years)
timeFrame: 10 years
Secondary outcomes:
measure: Invasion of sentinel lymph node biopsy
timeFrame: 2003-2009
Other outcomes:
Locations:
city: Boulogne Billancourt
country: France
facility: Pr Philippe Saiag
state: Ile De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe Saiag, MD
role: PRINCIPAL_INVESTIGATOR
References: