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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

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

  • 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

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

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

Fundación Academia Española de Dermatología

Investigators

  • 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)

September 1, 2016

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

July 18, 2018

First Submitted That Met QC Criteria

August 22, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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