Clinical trial NCT03605771: Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain
Official title: Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma Stage Iv
Melanoma Stage Iii
Advanced Cancer
Lead sponsor: Grupo Español Multidisciplinar de Melanoma
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A 'case' is defined as any patient, diagnosed, treated, or followed in the different health centres where reporting physicians authorised by the GEM group work, who meets the inclusion criteria.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sample Characteristics
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios
state: Alicante
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
state: Andalucía
city: Granada
country: Spain
facility: Onconogranada
state: Andalucía
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Málaga
state: Andalucía
city: Sabadell
country: Spain
facility: Parc Taulí
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
state: Castilla - La Mancha
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
state: Castilla y León
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
state: Castilla y León
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
state: Castilla y León
city: Badalona
country: Spain
facility: Instituto Catalán de Oncología Badalona
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu y Sant Pau
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Universitario Quirón Dexeus
state: Cataluña
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
state: Comunidad Valenciana
city: Cáceres
country: Spain
facility: Hospital Universitario San Pedro Alcántara
state: Extremadura
city: Donostia
country: Spain
facility: Onkologikoa
state: Guipuzcoa
city: Logroño
country: Spain
facility: Hospital San Pedro
state: La Rioja
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro-Majadahonda
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Llàtzer
state: Palma
city: Vitoria Gasteiz
country: Spain
facility: Hospital Universitario Araba Txagorritxu Victoria
state: País Vasco
city: Alcira
country: Spain
facility: Hospital La Ribera
state: Valencia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Lugo
country: Spain
facility: Hospital Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
Study officials:
affiliation: Hospital General Universitario Gregorio Marañón
name: Iván Márquez Rodas, M.D.
role: STUDY_CHAIR
affiliation: Clínica Universidad de Navarra
name: Salvador Martín Algarra, M.D.
role: PRINCIPAL_INVESTIGATOR
References: