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

October 3, 2019 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Boulogne Billancourt, Ile De France, France, 92100
        • Pr Philippe Saiag

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with anatomo-pathologically proved melanoma

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival (0-10 years) Disease free survival (0-10 years)
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Invasion of sentinel lymph node biopsy
Time Frame: 2003-2009
2003-2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Philippe Saiag, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2003

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (Estimate)

February 9, 2009

Study Record Updates

Last Update Posted (Actual)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P020927

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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