Clinical trial NCT03646422: AEDV Registry of Primary Cutaneous Lymphoma
Official title: Spanish Academy of Dermatology and Venereology (AEDV) Registry of Primary Cutaneous Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma, T-Cell, Cutaneous
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Large B-Cell, Diffuse
Sezary Syndrome
Lymphoma, Extranodal NK-T-Cell
Lymphoma, B-Cell
Lead sponsor: Fundación Academia Española de Dermatología
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population should be an accurate representation of patients with primary cutaneous lymphoma in Spain

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.

Eligibility criteria: Inclusion Criteria:

* All consecutive patients with primary cutaneous lymphoma

Exclusion Criteria:

* Not willing to participate

Primary outcomes:
measure: Maximum TNM stage
timeFrame: Through study completion, an average every 1 year
measure: Therapeutic groups used
timeFrame: Through study completion, an average every 1 year
measure: Mortality
timeFrame: Through study completion, an average every 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
city: L'Hospitalet De Llobregat
country: Spain
facility: hospital Universitari de Bellvitge
city: Las Palmas De Gran Canaria
country: Spain
facility: C.H.U. Insular-Materno Infantil
city: Madrid
country: Spain
facility: H.U. Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Príncipe de Asturias
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Pontevedra
country: Spain
facility: CHOP-Hospital de Montecelo
city: Santa Cruz De Tenerife
country: Spain
facility: H.U. Nuestra Señora de la Candelaria
city: Sevilla
country: Spain
facility: H.U. Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Valencia-Clínico Malva-Rosa
Study officials:
affiliation: Hospital 12 de Octubre
name: Pablo Ortiz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Penate Y, Servitje O, Machan S, Fernandez-de-Misa R, Estrach MT, Acebo E, Mitxelena J, Ramon MD, Florez A, Blanes M, Morillo M, Medina S, Bassas J, Zayas A, Espinosa P, Perez A, Gonzalez-Romero N, Dominguez JD, Muniesa C, Lopez Robles J, Combalia A, Yanguas I, Suh H, Polo-Rodriguez I, Bielsa I, Mateu A, Ferrer B, Descalzo MA, Garcia-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.