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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

Tracking Information
First Submitted Date July 18, 2018
First Posted Date August 24, 2018
Last Update Posted Date November 26, 2018
Actual Study Start Date September 1, 2016
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 22, 2018)
  • Maximum TNM stage [ Time Frame: 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)
  • Mortality [ Time Frame: Through study completion, an average every 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title AEDV Registry of Primary Cutaneous Lymphoma
Official Title Spanish Academy of Dermatology and Venereology (AEDV) Registry of Primary Cutaneous Lymphoma
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study population should be an accurate representation of patients with primary cutaneous lymphoma in Spain
Condition
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Large B-Cell, Diffuse
  • Sezary Syndrome
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, B-Cell
Intervention Other: Registry of patients (exposure is Cutaneous Lymphoma)
Study Groups/Cohorts Not Provided
Publications * Peñate Y, Servitje O, Machan S, Fernández-de-Misa R, Estrach MT, Acebo E, Mitxelena J, Ramón MD, Flórez A, Blanes M, Morillo M, Medina S, Bassas J, Zayas A, Espinosa P, Pérez A, Gónzalez-Romero N, Domínguez JD, Muniesa C, López Robles J, Combalia A, Yanguas I, Suh H, Polo-Rodríguez I, Bielsa I, Mateu A, Ferrer B, Descalzo MA, García-Doval I, Ortiz-Romero PL. The First Year of the AEVD Primary Cutaneous Lymphoma Registry. Actas Dermosifiliogr. 2018 Sep;109(7):610-616. doi: 10.1016/j.ad.2018.03.006. Epub 2018 Apr 19. English, Spanish.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 22, 2018)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All consecutive patients with primary cutaneous lymphoma

Exclusion Criteria:

  • Not willing to participate
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Ignacio Garcia-Doval +34 91 544 62 84 investigacion@AEDV.ES
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03646422
Other Study ID Numbers FAE-LIN-2016-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Fundación Academia Española de Dermatología
Study Sponsor Fundación Academia Española de Dermatología
Collaborators Not Provided
Investigators Not Provided
PRS Account Fundación Academia Española de Dermatología
Verification Date August 2018