Multicentric Cohort of Melanoma Patients in Ile de France Area

NCT ID: NCT00839410

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1255 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2019-10-31

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.

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.

Conditions

Melanoma; Genetic Polymorphism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Saiag, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Pr Philippe Saiag

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

Countries

France

Other Identifiers

P020927

Identifier Type: -

Identifier Source: org_study_id