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Multicentric Cohort of Melanoma Patients in Ile de France Area


N/A
18 Years
N/A
Open (Enrolling)
Both
Melanoma, Genetic Polymorphism

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Trial Information

Multicentric Cohort of Melanoma Patients in Ile de France Area


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.

Inclusion 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Overall survival (0-10 years) Disease free survival (0-10 years)

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Philippe Saiag, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P020927

NCT ID:

NCT00839410

Start Date:

September 2003

Completion Date:

December 2018

Related Keywords:

  • Melanoma
  • Genetic Polymorphism
  • skin cancer
  • melanoma
  • sentinel lymph node biopsy
  • bio bank
  • genetic polymorphism
  • prospective cohort
  • cohort
  • sentinel lymph nodes
  • tissue samples
  • Melanoma

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