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

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ClinicalTrials.gov Identifier: NCT00839410
Recruitment Status : Active, not recruiting
First Posted : February 9, 2009
Last Update Posted : October 13, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Melanoma Genetic Polymorphism

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.

Study Design

Study Type : Observational
Actual Enrollment : 1255 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentric Cohort of Melanoma Patients in Ile de France Area
Actual Study Start Date : September 2003
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Overall survival (0-10 years) Disease free survival (0-10 years) [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Invasion of sentinel lymph node biopsy [ Time Frame: 2003-2009 ]

Biospecimen Retention:   Samples With DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with anatomo-pathologically proved melanoma

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839410

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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00839410     History of Changes
Other Study ID Numbers: P020927
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

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

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