Multicentric Cohort of Melanoma Patients in Ile de France Area

Melanoma Clinical Trial

— Melan-Cohort  

Official title:

Multicentric Cohort of Melanoma Patients in Ile de France Area

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839410
• Other study ID #: P020927
• Status: Completed
• Start date: September 2003
• Est. completion date: October 2019

Study information

• Verified date: September 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1255
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Genetic Polymorphism
• Melanoma

Locations

Country	Name	City	State
France	Pr Philippe Saiag	Boulogne Billancourt	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (0-10 years) Disease free survival (0-10 years)		10 years
Secondary	Invasion of sentinel lymph node biopsy		2003-2009