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
  Purpose

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.


Condition
Melanoma
Genetic Polymorphism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentric Cohort of Melanoma Patients in Ile de France Area

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Overall survival (0-10 years) Disease free survival (0-10 years) [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Invasion of sentinel lymph node biopsy [ Time Frame: 2003-2009 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA,RNA,SERUM,PLASMA,PROTEOMICS


Enrollment: 1255
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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with anatomo-pathologically proved melanoma

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00839410

Locations
France
Pr Philippe Saiag
Boulogne Billancourt, Ile de France, France, 92100
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Philippe Saiag, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00839410     History of Changes
Other Study ID Numbers: P020927
Study First Received: February 6, 2009
Last Updated: September 9, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
skin cancer
melanoma
sentinel lymph node biopsy
bio bank
genetic polymorphism
prospective cohort
cohort
sentinel lymph nodes
tissue samples

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 21, 2014