AEDV Registry of Primary Cutaneous Lymphoma

Sponsor
Fundación Academia Española de Dermatología (Other)
Overall Status
Recruiting
CT.gov ID
NCT03646422
Collaborator
(none)
2,000
14
100
142.9
1.4

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Spanish Academy of Dermatology and Venereology (AEDV) Registry of Primary Cutaneous Lymphoma
Actual Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Maximum TNM stage [Through study completion, an average every 1 year]

    Proportion

  2. Therapeutic groups used [Through study completion, an average every 1 year]

    Including drugs, phototherapy, radiotherapy and procedures (blood marrow transplant)

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

    Rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All consecutive patients with primary cutaneous lymphoma
Exclusion Criteria:
  • Not willing to participate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clinic Barcelona Spain
2 Hospital Universitario Basurto Bilbao Spain
3 Hospital General de Ciudad Real Ciudad Real Spain
4 hospital Universitari de Bellvitge L'Hospitalet De Llobregat Spain
5 C.H.U. Insular-Materno Infantil Las Palmas De Gran Canaria Spain
6 H.U. Fundación Jiménez Díaz Madrid Spain
7 Hospital 12 de Octubre Madrid Spain
8 Hospital Universitario Príncipe de Asturias Madrid Spain
9 Complejo Hospitalario de Navarra Pamplona Spain
10 CHOP-Hospital de Montecelo Pontevedra Spain
11 H.U. Nuestra Señora de la Candelaria Santa Cruz De Tenerife Spain
12 H.U. Virgen del Rocío Sevilla Spain
13 Hospital General Universitario de Valencia Valencia Spain
14 Hospital Valencia-Clínico Malva-Rosa Valencia Spain

Sponsors and Collaborators

  • Fundación Academia Española de Dermatología

Investigators

  • Principal Investigator: Pablo Ortiz, MD, PhD, Hospital 12 de Octubre

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Fundación Academia Española de Dermatología
ClinicalTrials.gov Identifier:
NCT03646422
Other Study ID Numbers:
  • FAE-LIN-2016-01
First Posted:
Aug 24, 2018
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022