Multicentric Cohort of Melanoma Patients in Ile de France Area (Melan-Cohort)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00839410
First received: February 6, 2009
Last updated: September 9, 2014
Last verified: August 2009

February 6, 2009
September 9, 2014
September 2003
July 2018   (final data collection date for primary outcome measure)
Overall survival (0-10 years) Disease free survival (0-10 years) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00839410 on ClinicalTrials.gov Archive Site
Invasion of sentinel lymph node biopsy [ Time Frame: 2003-2009 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multicentric Cohort of Melanoma Patients in Ile de France Area
Multicentric Cohort of Melanoma Patients in Ile de France Area

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

DNA,RNA,SERUM,PLASMA,PROTEOMICS

Non-Probability Sample

Adults with anatomo-pathologically proved melanoma

  • Melanoma
  • Genetic Polymorphism
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1255
December 2018
July 2018   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00839410
P020927
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Philippe Saiag, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP