Multicentric Cohort of Melanoma Patients in Ile de France Area

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00839410

Acronym

Melan-Cohort

Enrollment

1255

Registered

2009-02-09

Start date

2003-09-30

Completion date

2019-10-31

Last updated

2019-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Polymorphism, Melanoma

Keywords

skin cancer, melanoma, sentinel lymph node biopsy, bio bank, genetic polymorphism, prospective cohort, cohort, sentinel lymph nodes, tissue samples

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Overall survival (0-10 years) Disease free survival (0-10 years)	10 years

Secondary

Measure	Time frame
Invasion of sentinel lymph node biopsy	2003-2009

Countries

France

Outcome results