Skip to main content
OpenTrials
Completed

NCT Number: NCT00839410

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pr Philippe Saiag

Boulogne-Billancourt, Île-de-France Region, 92100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 10 years

Secondary outcomes

  1. Invasion of sentinel lymph node biopsy

    Time frame: 2003-2009

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: Melan-Cohort

Important dates

Study start
2003
Primary completion
2019
Study completion
2019
First posted
Feb 9, 2009
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.