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

Status: Recruiting
Location: See all (39) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients of legal age with stage III, metastatic, or unresectable melanoma at first diagnosis after January 8, 2018. 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 1.

• 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.

Locations
Other Locations
Spain
Hospital Virgen de los Lirios
RECRUITING
Alcoy
Hospital La Ribera
RECRUITING
Alzira
Instituto Catalán de Oncología Badalona
RECRUITING
Badalona
Hospital de la Santa Creu y Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Quirón Dexeus
RECRUITING
Barcelona
Hospital Universitario de Burgos
RECRUITING
Burgos
Hospital Universitario San Pedro Alcántara
RECRUITING
Cáceres
Hospital General de Ciudad Real
RECRUITING
Ciudad Real
Onkologikoa
RECRUITING
Donostia / San Sebastian
Hospital Clínico Universitario Virgen de la Arrixaca
RECRUITING
El Palmar
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Onconogranada
NOT_YET_RECRUITING
Granada
Hospital San Pedro
RECRUITING
Logroño
Hospital Lucus Augusti
RECRUITING
Lugo
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital General Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario La Princesa
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro-Majadahonda
RECRUITING
Majadahonda
Hospital Universitario Regional de Málaga
RECRUITING
Málaga
Hospital Costa del Sol
RECRUITING
Marbella
Hospital Universitario Son Llàtzer
RECRUITING
Palma De Mallorca
Clínica Universidad de Navarra
RECRUITING
Pamplona
Complejo Hospitalario de Navarra
RECRUITING
Pamplona
Complejo Hospitalario de Pontevedra
RECRUITING
Pontevedra
Parc Taulí
RECRUITING
Sabadell
Complejo Asistencial Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario de Valme
RECRUITING
Seville
Hospital Virgen de la Salud
RECRUITING
Toledo
Hospital General Universitario de Valencia
RECRUITING
Valencia
Instituto Valenciano de Oncología
NOT_YET_RECRUITING
Valencia
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
Hospital Universitario Río Hortega
RECRUITING
Valladolid
Hospital Universitario Araba Txagorritxu Victoria
RECRUITING
Vitoria-gasteiz
Hospital Clínico Universitario Lozano Blesa
RECRUITING
Zaragoza
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
A responsible person designated by the sponsor
investigacion@mfar.net
+34 93 434 44 12
Backup
Responsible person designated by the sponsor
investigacion@mfar.net
+34 93 434 44 12
Time Frame
Start Date: 2018-08-07
Estimated Completion Date: 2025-12
Participants
Target number of participants: 400
Treatments
Advanced Melanoma
Patients of legal age with stage III, metastatic, or unresectable melanoma at first diagnosis after January 8, 2018. First diagnosis is understood as:~1. Disease onset as metastatic or unresectable disease.~2. 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.
Related Therapeutic Areas
Sponsors
Leads: Grupo Español Multidisciplinar de Melanoma

This content was sourced from clinicaltrials.gov

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