Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain
Recruiting · NCT03605771 · Observational (researchers observe without assigning treatment) · Lead sponsor: Grupo Español Multidisciplinar de Melanoma
View the official record on ClinicalTrials.gov →Interventions studied
Daily Clinical Practice
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
39 locations listed.
- Hospital Clínico San Carlos - Madrid, Spain
- Hospital General Universitario Gregorio Marañón - Madrid, Spain
- Clínica Universidad de Navarra - Pamplona, Spain
- Hospital Virgen de los Lirios - Alcoy, Alicante, Spain
- Hospital Universitario Virgen de las Nieves - Granada, Andalusia, Spain
- Onconogranada - Granada, Andalusia, Spain
- Hospital Universitario Regional de Málaga - Málaga, Andalusia, Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Barcelona, Spain
- Parc Taulí - Sabadell, Barcelona, Spain
- Hospital Universitario Araba Txagorritxu Victoria - Vitoria-Gasteiz, Basque Country, Spain
- Hospital Universitario Marqués de Valdecilla - Santander, Cantabria, Spain
- Hospital Universitario de Burgos - Burgos, Castille and León, Spain
- Complejo Asistencial Universitario de Salamanca - Salamanca, Castille and León, Spain
- Hospital Universitario Río Hortega - Valladolid, Castille and León, Spain
- Hospital General de Ciudad Real - Ciudad Real, Castille-La Mancha, Spain
- Instituto Catalán de Oncología Badalona - Badalona, Catalonia, Spain
- Hospital de la Santa Creu y Sant Pau - Barcelona, Catalonia, Spain
- Hospital Universitario Quirón Dexeus - Barcelona, Catalonia, Spain
- Hospital Universitario San Pedro Alcántara - Cáceres, Extremadura, Spain
- Onkologikoa - Donostia / San Sebastian, Guipuzcoa, Spain
- Hospital San Pedro - Logroño, La Rioja, Spain
- Hospital Lucus Augusti - Lugo, Lugo, Spain
- Hospital Universitario La Princesa - Madrid, Madrid, Spain
- Hospital Universitario La Paz - Madrid, Madrid, Spain
- Hospital Universitario Ramón y Cajal - Madrid, Madrid, 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, Navarre, Spain
- Hospital Universitario Son Llàtzer - Palma de Mallorca, Palma, Spain
- Complejo Hospitalario de Pontevedra - Pontevedra, Pontevedra, Spain
- Hospital Universitario de Valme - Seville, Sevilla, Spain
- Hospital Virgen de la Salud - Toledo, Toledo, Spain
- Hospital La Ribera - Alzira, Valencia, Spain
- Hospital General Universitario de Valencia - Valencia, Valencia, Spain
- Instituto Valenciano de Oncología - Valencia, Valencia, Spain
- Hospital Clínico Universitario de Valladolid - Valladolid, Valladolid, Spain
- Hospital Universitario Miguel Servet - Zaragoza, Zaragoza, Spain
- Hospital Clínico Universitario Lozano Blesa - Zaragoza, Zaragoza, Spain