Spanish Academy of Dermatology and Venereology (AEDV) Melanoma Registry

Recruiting

• Conditions: Melanoma

• Registration Number: NCT05673681
• Lead Sponsor: Fundación Academia Española de Dermatología

Brief Summary

The goal of this patient registry is to describe risk factors for bad prognosis of melanoma in Spain. The main questions it aims to answer are:

* To describe socioeconomical individual risk factors associated with melanoma prognosis, such as gender, residence area or socioeconomic level.

* To describe potentially modifiable characteristics of health care associated with prognosis, such as waiting times, type of centre that makes the diagnosis or use of teledermatology Participants data will be gathered for analysis, without any change in the way that they are being treated.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-02
• Study First Submitted QC: 2023-01-05
• Last Update Submitted: 2023-01-05
• Study First Posted: 2023-01-06
• Last Update Posted: 2023-01-09
• Primary Completion: 2032-06-01
• Study Completion: 2032-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7000

Inclusion Criteria

• All consecutive patients with a diagnosis of invasive primary cutaneous melanoma in participating centres.

Exclusion Criteria

• In-situ melanomas
• non-cutaneous melanomas,
• metastatic melanoma with unknown primary site.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AJCC (American Joint Committee on Cancer) TNM stage (Tumor, node, metastasis)	1 day At diagnosis	Staging based on tumor thickness and ulceration, spread to lymph nodes and spread to distant sites.
Breslow thickness	1 day At diagnosis	Breslow thickness is the measurement of the depth of the melanoma from the surface of your skin down through to the deepest point of the tumour.

Secondary Outcome Measures

Name	Time	Method
Time to progression	through study completion, an average of 3 years
Survival	through study completion, an average of 3 years

Trial Locations

Locations (21)

Hospital Universitario de Gran Canaria Dr Negrín; 🇪🇸 Las Palmas, Spain

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital San Juan de Dios; 🇪🇸 Córdoba, Spain

Hospital Puerta de Hierro Majadahonda; 🇪🇸 Madrid, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Ruber Internacional; 🇪🇸 Madrid, Spain

Hospital Central de Asturias; 🇪🇸 Oviedo, Spain

Instituto Valenciano de Oncología; 🇪🇸 Valencia, Spain

Complexo Hospitalario Universitario de A Coruña; 🇪🇸 A Coruña, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Clínica Universitaria de Navarra ( sede de Madrid); 🇪🇸 Madrid, Spain

Complejo Asistencial Universitario de León; 🇪🇸 León, Spain

Hospital Son LLàtzer; 🇪🇸 Palma De Mallorca, Spain

Hospital Universitario Virgen Macarena de Sevilla; 🇪🇸 Sevilla, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Clínica Dermatológica Internacional; 🇪🇸 Madrid, Spain

Complexo Hospitalario Universitario de Pontevedra; 🇪🇸 Pontevedra, Spain

H.U. Nuestra Señora de la Candelaria; 🇪🇸 Santa Cruz De Tenerife, Spain

Hospital La Fé; 🇪🇸 Valencia, Spain

Quirón Salud Sevilla; 🇪🇸 Sevilla, Spain