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

Advanced Cancer Clinical Trial

— GEM-1801  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03605771
• Other study ID #: GEM-1801
• Status: Recruiting
• Start date: August 7, 2018
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Grupo Español Multidisciplinar de Melanoma
• Contact: A responsible person designated by the sponsor
• Phone: +34 93 434 44 12
• Email: investigacion[@]mfar.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Melanoma
• Melanoma Stage Iii
• Melanoma Stage Iv

Intervention

Other:
• Daily Clinical Practice
The assignment of a patient to a specific therapeutic strategy will not be decided in advance by the study protocol, but will be determined by the usual clinical practice of medicine, and the decision to prescribe a specific treatment will be clearly dissociated from the decision to include a patient in the study. No intervention will be applied to patients, either diagnostic or follow-up, other than the usual clinical practice.

Locations

Country	Name	City	State
Spain	Hospital La Ribera	Alcira	Valencia
Spain	Hospital Virgen de los Lirios	Alcoy	Alicante
Spain	Instituto Catalán de Oncología Badalona	Badalona	Cataluña
Spain	Hospital de la Santa Creu y Sant Pau	Barcelona	Cataluña
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Quirón Dexeus	Barcelona	Cataluña
Spain	Hospital Universitario de Burgos	Burgos	Castilla Y León
Spain	Hospital Universitario San Pedro Alcántara	Cáceres	Extremadura
Spain	Hospital General de Ciudad Real	Ciudad Real	Castilla - La Mancha
Spain	Onkologikoa	Donostia	Guipuzcoa
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Universitario Virgen de las Nieves	Granada	Andalucía
Spain	Onconogranada	Granada	Andalucía
Spain	Hospital San Pedro	Logroño	La Rioja
Spain	Hospital Lucus Augusti	Lugo
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro-Majadahonda	Majadahonda	Madrid
Spain	Hospital Universitario Regional de Málaga	Málaga	Andalucía
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital Universitario Son Llàtzer	Palma De Mallorca	Palma
Spain	Clínica Universidad de Navarra	Pamplona
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Complejo Hospitalario de Pontevedra	Pontevedra
Spain	Parc Taulí	Sabadell	Barcelona
Spain	Complejo Asistencial Universitario de Salamanca	Salamanca	Castilla Y León
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario de Valme	Sevilla
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hospital General Universitario de Valencia	Valencia	Comunidad Valenciana
Spain	Instituto Valenciano de Oncología	Valencia	Comunidad Valenciana
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital Universitario Río Hortega	Valladolid	Castilla Y León
Spain	Hospital Universitario Araba Txagorritxu Victoria	Vitoria Gasteiz	País Vasco
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Español Multidisciplinar de Melanoma

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sample Characteristics	Sociodemographic and disease characteristics of patients diagnosed with stage III, metastatic or unresectable melanoma at first diagnosis.	Baseline