AEDV Registry of Primary Cutaneous Lymphoma

Lymphoma, B-Cell Clinical Trial

Official title:

Spanish Academy of Dermatology and Venereology (AEDV) Registry of Primary Cutaneous Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03646422
• Other study ID #: FAE-LIN-2016-01
• Status: Recruiting
• Start date: September 1, 2016
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2022
• Source: Fundación Academia Española de Dermatología
• Contact: Ignacio Garcia-Doval, MD, PhD, MScEpid
• Phone: +34 91 544 62 84
• Email: investigacion[@]AEDV.ES
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All consecutive patients with primary cutaneous lymphoma

Exclusion Criteria:

• Not willing to participate

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Sezary Syndrome

Intervention

Other:
• Registry of patients (exposure is Cutaneous Lymphoma)

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona
Spain	Hospital Universitario Basurto	Bilbao
Spain	Hospital General de Ciudad Real	Ciudad Real
Spain	hospital Universitari de Bellvitge	L'Hospitalet De Llobregat
Spain	C.H.U. Insular-Materno Infantil	Las Palmas De Gran Canaria
Spain	H.U. Fundación Jiménez Díaz	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Universitario Príncipe de Asturias	Madrid
Spain	Complejo Hospitalario de Navarra	Pamplona
Spain	CHOP-Hospital de Montecelo	Pontevedra
Spain	H.U. Nuestra Señora de la Candelaria	Santa Cruz De Tenerife
Spain	H.U. Virgen del Rocío	Sevilla
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital Valencia-Clínico Malva-Rosa	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Academia Española de Dermatología

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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 (Engl Ed). 2018 Sep;109(7):610-616. doi: 10.1016/j.ad.2018.03.006. Epub 2018 Apr 19. English, Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum TNM stage	Proportion	Through study completion, an average every 1 year
Primary	Therapeutic groups used	Including drugs, phototherapy, radiotherapy and procedures (blood marrow transplant)	Through study completion, an average every 1 year
Primary	Mortality	Rate	Through study completion, an average every 1 year

External Links

•   Updated description of the study (in Spanish)