Overview

This trial is active, not recruiting.

Conditions melanoma, genetic polymorphism
Sponsor Assistance Publique - Hôpitaux de Paris
Start date September 2003
End date July 2018
Trial size 1255 participants
Trial identifier NCT00839410, P020927

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Overall survival (0-10 years) Disease free survival (0-10 years)
time frame: 10 years

Secondary Outcomes

Measure
Invasion of sentinel lymph node biopsy
time frame: 2003-2009

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Multicentric Cohort of Melanoma Patients in Ile de France Area
Principal investigator Philippe Saiag, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.