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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03605771
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Grupo Español Multidisciplinar de Melanoma
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Iván Márquez Rodas, M.D.Salvador Martín Algarra, M.D.
Principal Investigator Affiliation	Hospital General Universitario Gregorio MarañónClínica Universidad de Navarra
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma Stage Iv, Melanoma Stage Iii, Advanced Cancer

Arms & Interventions

Arms

: 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: Disease onset as metastatic or unresectable disease. 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital Virgen de los Lirios, Alcoy, Alicante, Spain

Status

Recruiting

Address

Hospital Virgen de los Lirios

Alcoy, Alicante, 03804

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