AEDV Registry of Primary Cutaneous Lymphoma

March 15, 2022 updated by: Fundación Academia Española de Dermatología

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ignacio Garcia-Doval, MD, PhD, MScEpid
  • Phone Number: +34 91 544 62 84
  • Email: investigacion@AEDV.ES

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic
        • Contact:
          • Teresa Estrach Panella
      • Bilbao, Spain
        • Recruiting
        • Hospital Universitario Basurto
        • Contact:
          • Rosa Izu Belloso
      • Ciudad Real, Spain
        • Recruiting
        • Hospital General de Ciudad Real
        • Contact:
          • Prado Sanchez Caminero
      • L'Hospitalet De Llobregat, Spain
        • Recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
          • Octavio Servitje Bedate
      • Las Palmas De Gran Canaria, Spain
        • Recruiting
        • C.H.U. Insular-Materno Infantil
        • Contact:
          • Yeray Peñate Santana
      • Madrid, Spain
        • Recruiting
        • H.U. Fundación Jiménez Díaz
        • Contact:
          • Salma Machan
      • Madrid, Spain
        • Recruiting
        • Hospital 12 de Octubre
        • Contact:
          • Pablo Ortiz
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Príncipe de Asturias
        • Contact:
          • Susana Medina Montalvo
      • Pamplona, Spain
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
          • Juan Ignacio Yanguas Bayona
      • Pontevedra, Spain
        • Recruiting
        • CHOP-Hospital de Montecelo
        • Contact:
          • Ángeles Flórez Menéndez
      • Santa Cruz De Tenerife, Spain
        • Recruiting
        • H.U. Nuestra Señora de la Candelaria
        • Contact:
          • Ricardo Fernandez de Misa Cabrera
      • Sevilla, Spain
        • Recruiting
        • H.U. Virgen del Rocío
        • Contact:
          • Mercedes Morillo Andújar
      • Valencia, Spain
        • Recruiting
        • Hospital General Universitario de Valencia
        • Contact:
          • Amparo Pérez Ferrer Ferriols
      • Valencia, Spain
        • Recruiting
        • Hospital Valencia-Clínico Malva-Rosa
        • Contact:
          • María Dolores Ramón Quiles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population should be an accurate representation of patients with primary cutaneous lymphoma in Spain

Description

Inclusion Criteria:

  • All consecutive patients with primary cutaneous lymphoma

Exclusion Criteria:

  • Not willing to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum TNM stage
Time Frame: Through study completion, an average every 1 year
Proportion
Through study completion, an average every 1 year
Therapeutic groups used
Time Frame: Through study completion, an average every 1 year
Including drugs, phototherapy, radiotherapy and procedures (blood marrow transplant)
Through study completion, an average every 1 year
Mortality
Time Frame: Through study completion, an average every 1 year
Rate
Through study completion, an average every 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Academia Española de Dermatología

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pablo Ortiz, MD, PhD, Hospital 12 de Octubre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FAE-LIN-2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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