MelanomaNCT05673681
Spanish Academy of Dermatology and Venereology (AEDV) Melanoma Registry
An observational study of Melanoma, run by Fundación Academia Española de Dermatología at 21 sites in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma
- How many people
- 7,000 participants
- Where
- 21 sitesSpain
- Study dates
- 1 Jun 2022to 1 Jun 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients with a diagnosis of invasive primary cutaneous melanoma in participating centres.
Who may be able to join
- All consecutive patients with a diagnosis of invasive primary cutaneous melanoma in participating centres.
Who cannot join
- In-situ melanomas
- non-cutaneous melanomas,
- metastatic melanoma with unknown primary site.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ignacio Garcia-Doval, PhD contact
21 sites in 1 country
Spain21 sites, 21 recruiting
- Not yet recruiting
Complexo Hospitalario Universitario de A Coruña
A Coruña
Sabela Paradela
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona
Aram Boada, MD
Nina Richarz
- Recruiting
Hospital Clinic
Barcelona
Susana Puig, PhD
- Recruiting
Hospital San Juan de Dios
Córdoba
Antonio Tejera, PhD
- Recruiting
Hospital Universitario de Gran Canaria Dr Negrín
Las Palmas
Elena Castro, MD
- Recruiting
Complejo Asistencial Universitario de León
León
Elia Samaniego González, MD
- Not yet recruiting
Clínica Dermatológica Internacional
Madrid
Pedro Rodríguez Jiménez
- Recruiting
Clínica Universitaria de Navarra ( sede de Madrid)
Madrid
Alejandra Tomás Velázquez
- Recruiting
Hospital Clínico San Carlos
Madrid
Alberto Conde Taboada, PhD
- Recruiting
Hospital La Paz
Madrid
Ander Mayor
- Not yet recruiting
Hospital Puerta de Hierro Majadahonda
Madrid
Gastón Roustan
Irene Salgüero
- Not yet recruiting
Ruber Internacional
Madrid
Pedro Rodríguez Jiménez
- Recruiting
Hospital Central de Asturias
Oviedo
Cayetana Maldonado
- Recruiting
Hospital Son LLàtzer
Palma de Mallorca
Rosa Taberner
Alex Llambrich
- Not yet recruiting
Complexo Hospitalario Universitario de Pontevedra
Pontevedra
Ángeles Flórez
- Recruiting
H.U. Nuestra Señora de la Candelaria
Santa Cruz de Tenerife
Ricardo Fernandez de Misa Cabrera
- Recruiting
Hospital Universitario Virgen Macarena de Sevilla
Seville
Lara Ferrándiz
- Not yet recruiting
Quirón Salud Sevilla
Seville
Tomás Toledo Pastrana
- Not yet recruiting
Hospital La Fé
Valencia
Rafael Botella
Blanca Unamuno
- Recruiting
Instituto Valenciano de Oncología
Valencia
Eduardo Nagore Enguidanos, PhD
- Not yet recruiting
Hospital Miguel Servet
Zaragoza
Yolanda Gilaberte
Adrian Diago
About this study
Official title: Registro de Melanoma de la AEDV
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.
- Conditions
- Melanoma
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day At diagnosis
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.
Measured: 1 day At diagnosis
Secondary outcomes (2)
Time to progression
Measured: through study completion, an average of 3 years
Survival
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2032 (estimated)
- Study completion1 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Fundación Academia Española de Dermatología
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673681
- Sponsor's protocol ID
- FAE-MEL-2022-01
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registro de Melanoma de la AEDV
- ClinicalTrials.gov ID
- NCT05673681
- Acronym / sponsor ID
- FAE-MEL-2022-01
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Fundación Academia Española de DermatologíaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2032 (estimated)
- Study completion
- 1 Jun 2032 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients with a diagnosis of invasive primary cutaneous melanoma in participating centres.
Key inclusion criteria (1 listed)
- All consecutive patients with a diagnosis of invasive primary cutaneous melanoma in participating centres.
Key exclusion criteria (3 listed)
- In-situ melanomas
- non-cutaneous melanomas,
- metastatic melanoma with unknown primary site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AJCC (American Joint Committee on Cancer) TNM stage (Tumor, node, metastasis)
Time frame: 1 day At diagnosis
Staging based on tumor thickness and ulceration, spread to lymph nodes and spread to distant sites.
Breslow thickness
Time frame: 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.
2 secondary outcomes
Time to progression
Time frame: through study completion, an average of 3 years
Survival
Time frame: through study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ignacio Garcia-Doval, PhD contact
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Fundación Academia Española de Dermatología at 21 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mercè Grau, MD (34 91 544 62 84, merce.grau@equipo.aedv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AJCC (American Joint Committee on Cancer) TNM stage (Tumor, node, metastasis) (time frame: 1 day At diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.