Spanish Academy of Dermatology and Venereology (AEDV) Melanoma Registry

Melanoma Clinical Trial

Official title:

Registro de Melanoma de la AEDV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673681
• Other study ID #: FAE-MEL-2022-01
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 1, 2032

Study information

• Verified date: January 2023
• Source: Fundación Academia Española de Dermatología
• Contact: Mercè Grau, MD
• Phone: 34 91 544 62 84
• Email: merce.grau[@]equipo.aedv.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: June 1, 2032
• Est. primary completion date: June 1, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
Spain	Complexo Hospitalario Universitario de A Coruña	A Coruña
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic	Barcelona
Spain	Hospital San Juan de Dios	Córdoba
Spain	Hospital Universitario de Gran Canaria Dr Negrín	Las Palmas
Spain	Complejo Asistencial Universitario de León	León
Spain	Clínica Dermatológica Internacional	Madrid
Spain	Clínica Universitaria de Navarra ( sede de Madrid)	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Puerta de Hierro Majadahonda	Madrid
Spain	Ruber Internacional	Madrid
Spain	Hospital Central de Asturias	Oviedo
Spain	Hospital Son LLàtzer	Palma De Mallorca
Spain	Complexo Hospitalario Universitario de Pontevedra	Pontevedra
Spain	H.U. Nuestra Señora de la Candelaria	Santa Cruz De Tenerife
Spain	Hospital Universitario Virgen Macarena de Sevilla	Sevilla
Spain	Quirón Salud Sevilla	Sevilla
Spain	Hospital La Fé	Valencia
Spain	Instituto Valenciano de Oncología	Valencia
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Academia Española de Dermatología

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AJCC (American Joint Committee on Cancer) TNM stage (Tumor, node, metastasis)	Staging based on tumor thickness and ulceration, spread to lymph nodes and spread to distant sites.	1 day At diagnosis
Primary	Breslow thickness	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.	1 day At diagnosis
Secondary	Time to progression		through study completion, an average of 3 years
Secondary	Survival		through study completion, an average of 3 years