Multicentric Cohort of Melanoma Patients in Ile de France Area

NCT00839410 | Completed DMC

• 1 other identifier: P020927
• Study Type: observational
• Target: 1,255
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Genetic Polymorphism

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall survival (0-10 years) Disease free survival (0-10 years)

  10 years

Secondary Outcomes (1)

• Invasion of sentinel lymph node biopsy

  2003-2009

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with anatomo-pathologically proved melanoma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pr Philippe Saiag

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA,RNA,SERUM,PLASMA,PROTEOMICS

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Philippe Saiag, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: September 1, 2003
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-09

Locations

FR (1)