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

Recruiting

• Conditions: Melanoma Stage Iv; Advanced Cancer; Melanoma Stage Iii
• Interventions: Other: Daily Clinical Practice

• Registration Number: NCT03605771
• Lead Sponsor: Grupo Español Multidisciplinar de Melanoma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-30
• Study Start: 2018-08-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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.

Exclusion Criteria

• Any patient not complying with inclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advanced Melanoma	Daily Clinical Practice	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.

Primary Outcome Measures

Name	Time	Method
Sample Characteristics	Baseline	Sociodemographic and disease characteristics of patients diagnosed with stage III, metastatic or unresectable melanoma at first diagnosis.

Trial Locations

Locations (39)

Hospital Virgen de los Lirios; 🇪🇸 Alcoy, Alicante, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Andalucía, Spain

Onconogranada; 🇪🇸 Granada, Andalucía, Spain

Hospital Universitario Regional de Málaga; 🇪🇸 Málaga, Andalucía, Spain

Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital General de Ciudad Real; 🇪🇸 Ciudad Real, Castilla - La Mancha, Spain

Hospital Universitario de Burgos; 🇪🇸 Burgos, Castilla y León, Spain

Complejo Asistencial Universitario de Salamanca; 🇪🇸 Salamanca, Castilla y León, Spain

Hospital Universitario Río Hortega; 🇪🇸 Valladolid, Castilla y León, Spain

Instituto Catalán de Oncología Badalona; 🇪🇸 Badalona, Cataluña, Spain

Hospital de la Santa Creu y Sant Pau; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Universitario Quirón Dexeus; 🇪🇸 Barcelona, Cataluña, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Comunidad Valenciana, Spain

Instituto Valenciano de Oncología; 🇪🇸 Valencia, Comunidad Valenciana, Spain

Hospital Universitario San Pedro Alcántara; 🇪🇸 Cáceres, Extremadura, Spain

Onkologikoa; 🇪🇸 Donostia, Guipuzcoa, Spain

Hospital San Pedro; 🇪🇸 Logroño, La Rioja, Spain

Hospital Universitario Puerta de Hierro-Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain

Hospital Costa del Sol; 🇪🇸 Marbella, Málaga, Spain

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitario Son Llàtzer; 🇪🇸 Palma De Mallorca, Palma, Spain

Hospital Universitario Araba Txagorritxu Victoria; 🇪🇸 Vitoria Gasteiz, País Vasco, Spain

Hospital La Ribera; 🇪🇸 Alcira, Valencia, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Lucus Augusti; 🇪🇸 Lugo, Spain

Hospital Universitario La Princesa; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Clínica Universidad de Navarra; 🇪🇸 Pamplona, Spain

Complejo Hospitalario de Pontevedra; 🇪🇸 Pontevedra, Spain

Hospital Universitario de Valme; 🇪🇸 Sevilla, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Clínico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Spain