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

Launched by GRUPO ESPAÑOL MULTIDISCIPLINAR DE MELANOMA · Jul 20, 2018

Keywords

ClinConnect Summary

This clinical trial is studying patients with advanced melanoma, which is a type of skin cancer that has spread to other parts of the body or cannot be surgically removed. Researchers are collecting information from medical records of patients diagnosed with stage III or stage IV melanoma since January 8, 2018. The goal is to better understand the characteristics and treatment outcomes of these patients, which can help improve care for those with advanced melanoma.

To be eligible for this study, patients must be adults diagnosed with stage III, metastatic, or unresectable melanoma during the specified time frame. They need to sign an informed consent form, allowing researchers to use their medical information. Participants can expect to have their medical records reviewed over time, contributing to important research without needing additional treatments or visits beyond their usual care. It's important to note that patients can only participate in one center and that their information will be updated as needed with their consent if they receive care at different locations.

Gender

ALL

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.