Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain

Grupo Español Multidisciplinar de Melanoma39 sites in 1 country400 target enrollmentAugust 7, 2018

ConditionsMelanoma Stage Iv Melanoma Stage Iii Advanced Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Melanoma Stage Iv
Sponsor: Grupo Español Multidisciplinar de Melanoma
Enrollment: 400
Locations: 39
Primary Endpoint: Sample Characteristics
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an observational, multicentre epidemiological study with a longitudinal cohort in which information will be retrieved from medical records of patients with advanced metastatic or unresectable melanoma at first diagnosis.

Registry

clinicaltrials.gov

Start Date

August 7, 2018

End Date

December 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Grupo Español Multidisciplinar de Melanoma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients of legal age with stage III, metastatic, or unresectable melanoma at first diagnosis after January 8,
•First diagnosis is understood as: a. Disease onset as metastatic or unresectable disease; b. First metastatic or unresectable relapse in the pre-established dates (after January 8, 2018) in a patient with previous localised melanoma and completely resected on dates before the pre-inclusion period.
•Signing the Informed Consent Form (ICF).
•A patient may have received the first or subsequent treatments for metastatic or unresectable disease in a hospital other than the centre where the ICF was signed, as long as the patient meets the inclusion criteria
•A patient can only sign one ICF (cannot sign an ICF in two different centres).
•If a patient signs the ICF in a centre during the first-line therapy and then goes to another centre with consideration for the following lines: If the centre is associated with the GEM-1801 study, researchers will do their best to update the following lines and the patient status, introducing the new information in the centre where the ICF was initially signed. This information will be provided by the patient before contacting the principal investigator and always with prior consent of the patient, who will have previously provided the consent to contact by telephone for this purpose. If this second (or subsequent) centre is not associated with the GEM- 1801 study, this will be considered loss of follow-up, unless the patient returns to the GEM-1801 start centre, wherein the reporting physicians will do their best to update the information from other centres, always with prior patient consent, who will have previously signed the ICF; c) A patient card with the assigned code will be delivered.