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AEDV Registry of Primary Cutaneous Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03646422
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Fundación Academia Española de Dermatología

Brief 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.

Condition or disease Intervention/treatment
Lymphoma, T-Cell, Cutaneous Lymphoma, B-Cell, Marginal Zone Lymphoma, Large B-Cell, Diffuse Sezary Syndrome Lymphoma, Extranodal NK-T-Cell Lymphoma, B-Cell Other: Registry of patients (exposure is Cutaneous Lymphoma)

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Spanish Academy of Dermatology and Venereology (AEDV) Registry of Primary Cutaneous Lymphoma
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  1. Maximum TNM stage [ Time Frame: Through study completion, an average every 1 year ]
  2. Therapeutic groups used [ Time Frame: Through study completion, an average every 1 year ]
    Including drugs, phototherapy, radiotherapy and procedures (blood marrow transplant)

  3. Mortality [ Time Frame: Through study completion, an average every 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population should be an accurate representation of patients with primary cutaneous lymphoma in Spain
Criteria

Inclusion Criteria:

  • All consecutive patients with primary cutaneous lymphoma

Exclusion Criteria:

  • Not willing to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646422


Contacts
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Contact: Ignacio Garcia-Doval +34 91 544 62 84 investigacion@AEDV.ES

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

Additional Information:
Publications:
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Responsible Party: Fundación Academia Española de Dermatología
ClinicalTrials.gov Identifier: NCT03646422     History of Changes
Other Study ID Numbers: FAE-LIN-2016-01
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Sezary Syndrome
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, Extranodal NK-T-Cell
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin