Lymphoma, T-Cell, CutaneousNCT03646422
AEDV Registry of Primary Cutaneous Lymphoma
An observational study of Lymphoma, T-Cell, Cutaneous and Lymphoma, B-Cell, Marginal Zone, run by Fundación Academia Española de Dermatología at 14 sites in Spain.
Trial summary
Registry of patients with Primary Cutaneous Lymphoma seen at participating centers in Spain. The registry will identify patients with this disease and includes information about stage, diagnostic and therapeutic interventions and willingness to participate in further studies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, T-Cell, Cutaneous, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- Registry of patients (exposure is Cutaneous Lymphoma)
- How many people
- 2,000 participants
- Where
- 14 sitesSpain
- Study dates
- 1 Sep 2016to 1 Jan 2025
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Study population should be an accurate representation of patients with primary cutaneous lymphoma in Spain
Who may be able to join
- All consecutive patients with primary cutaneous lymphoma
Who cannot join
- Not willing to participate
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites, 14 recruiting
- Recruiting
Hospital Clinic
Barcelona
Teresa Estrach Panella
- Recruiting
Hospital Universitario Basurto
Bilbao
Rosa Izu Belloso
- Recruiting
Hospital General de Ciudad Real
Ciudad Real
Prado Sanchez Caminero
- Recruiting
hospital Universitari de Bellvitge
L'Hospitalet de Llobregat
Octavio Servitje Bedate
- Recruiting
C.H.U. Insular-Materno Infantil
Las Palmas de Gran Canaria
Yeray Peñate Santana
- Recruiting
H.U. Fundación Jiménez Díaz
Madrid
Salma Machan
- Recruiting
Hospital 12 de Octubre
Madrid
Pablo Ortiz
- Recruiting
Hospital Universitario Príncipe de Asturias
Madrid
Susana Medina Montalvo
- Recruiting
Complejo Hospitalario de Navarra
Pamplona
Juan Ignacio Yanguas Bayona
- Recruiting
CHOP-Hospital de Montecelo
Pontevedra
Ángeles Flórez Menéndez
- Recruiting
H.U. Nuestra Señora de la Candelaria
Santa Cruz de Tenerife
Ricardo Fernandez de Misa Cabrera
- Recruiting
H.U. Virgen del Rocío
Seville
Mercedes Morillo Andújar
- Recruiting
Hospital General Universitario de Valencia
Valencia
Amparo Pérez Ferrer Ferriols
- Recruiting
Hospital Valencia-Clínico Malva-Rosa
Valencia
María Dolores Ramón Quiles
About this study
Official title: Spanish Academy of Dermatology and Venereology (AEDV) Registry of Primary Cutaneous Lymphoma
Registry of patients with Primary Cutaneous Lymphoma seen at participating centers in Spain. The registry will identify patients with this disease and includes information about stage, diagnostic and therapeutic interventions and willingness to participate in further studies.
Read the detailed description
Registry of patients with Primary Cutaneous Lymphoma seen at participating centers in Spain. The registry will identify patients with this disease and includes information about stage, diagnostic and therapeutic interventions and willingness to participate in further studies.
Data is entered in the registry in each of the participating cutaneous lymphoma clinics. These data are updated at least yearly. Participants receive specific training before starting, and there is an online continuous monitoring system.
- Conditions
- Lymphoma, T-Cell, Cutaneous, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Sezary Syndrome, Lymphoma, Extranodal NK-T-Cell, Lymphoma, B-Cell
- Being tested
- Registry of patients (exposure is Cutaneous Lymphoma)
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Sezary Syndrome, Lymphoma, Extranodal NK-T-Cell, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registry of patients (exposure is Cutaneous Lymphoma)Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum TNM stage
Proportion
Measured: Through study completion, an average every 1 year
Therapeutic groups used
Including drugs, phototherapy, radiotherapy and procedures (blood marrow transplant)
Measured: Through study completion, an average every 1 year
Mortality
Rate
Measured: Through study completion, an average every 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Sep 2016
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, T-Cell, CutaneousStudies 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
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Fundación Academia Española de Dermatología
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pablo Ortiz, MD, PhD, Principal investigator, Hospital 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646422
- Sponsor's protocol ID
- FAE-LIN-2016-01
- Status last verified
- Mar 2022
- First submitted
- 18 Jul 2018
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Penate Y, Servitje O, Machan S, Fernandez-de-Misa R, Estrach MT, Acebo E, Mitxelena J, Ramon MD, Florez A, Blanes M, Morillo M, Medina S, Bassas J, Zayas A, Espinosa P, Perez A, Gonzalez-Romero N, Dominguez JD, Muniesa C, Lopez Robles J, Combalia A, Yanguas I, Suh H, Polo-Rodriguez I, Bielsa I, Mateu A, Ferrer B, Descalzo MA, Garcia-Doval I, Ortiz-Romero PL. The First Year of the AEVD Primary Cutaneous Lymphoma Registry. Actas Dermosifiliogr (Engl Ed). 2018 Sep;109(7):610-616. doi: 10.1016/j.ad.2018.03.006. Epub 2018 Apr 19. English, Spanish.
PubMed 29680323
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Academy of Dermatology and Venereology (AEDV) Registry of Primary Cutaneous Lymphoma
- ClinicalTrials.gov ID
- NCT03646422
- Acronym / sponsor ID
- FAE-LIN-2016-01
- Conditions
- Lymphoma, T-Cell, Cutaneous, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Sezary Syndrome, Lymphoma, Extranodal NK-T-Cell, Lymphoma, B-Cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fundación Academia Española de DermatologíaUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 24 Aug 2018 (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.
Registry of patients with Primary Cutaneous Lymphoma seen at participating centers in Spain. The registry will identify patients with this disease and includes information about stage, diagnostic and therapeutic interventions and willingness to participate in further studies.
Detailed description
Registry of patients with Primary Cutaneous Lymphoma seen at participating centers in Spain. The registry will identify patients with this disease and includes information about stage, diagnostic and therapeutic interventions and willingness to participate in further studies.
Data is entered in the registry in each of the participating cutaneous lymphoma clinics. These data are updated at least yearly. Participants receive specific training before starting, and there is an online continuous monitoring system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population should be an accurate representation of patients with primary cutaneous lymphoma in Spain
Key inclusion criteria (1 listed)
- All consecutive patients with primary cutaneous lymphoma
Key exclusion criteria (1 listed)
- Not willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Registry of patients (exposure is Cutaneous Lymphoma) | Other | – |
Primary outcome
Maximum TNM stage
Time frame: Through study completion, an average every 1 year
Proportion
Therapeutic groups used
Time frame: Through study completion, an average every 1 year
Including drugs, phototherapy, radiotherapy and procedures (blood marrow transplant)
Mortality
Time frame: Through study completion, an average every 1 year
Rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 29680323Penate Y, Servitje O, Machan S, Fernandez-de-Misa R, Estrach MT, Acebo E, Mitxelena J, Ramon MD, Florez A, Blanes M, Morillo M, Medina S, Bassas J, Zayas A, Espinosa P, Perez A, Gonzalez-Romero N, Dominguez JD, Muniesa C, Lopez Robles J, Combalia A, Yanguas I, Suh H, Polo-Rodriguez I, Bielsa I, Mateu A, Ferrer B, Descalzo MA, Garcia-Doval I, Ortiz-Romero PL. The First Year of the AEVD Primary Cutaneous Lymphoma Registry. Actas Dermosifiliogr (Engl Ed). 2018 Sep;109(7):610-616. doi: 10.1016/j.ad.2018.03.006. Epub 2018 Apr 19. English, Spanish.
- 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. This study is not recruiting at the moment.
Pablo Ortiz, MD, PhD principal investigator
Hospital 12 de Octubre
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, T-Cell, Cutaneous and Lymphoma, B-Cell, Marginal Zone, run by Fundación Academia Española de Dermatología at 14 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 1 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ignacio Garcia-Doval, MD, PhD, MScEpid (+34 91 544 62 84, investigacion@AEDV.ES), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum TNM stage (time frame: Through study completion, an average every 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03646422, which also lists 1 linked publication.
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 31 Mar 2022.