Clinical trial NCT03855592: Registry of Thrombosis & NEoplasia of "Sociedad Española de Oncología Médica"
Official title: Observational Epidemiological Study of Cancer-associated Thrombosis: Registry of Thrombosis & NEoplasia of SEOM (TESEO Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thromboembolism
Cancer
Lead sponsor: Fundación Sociedad Española de Oncologia Médica
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients

Brief summary: Epidemiological, observational, non-interventional, multicentric study on patients diagnosed with cancer who develop a venous or arterial thromboembolic episode, symptomatic or incidental, within a month prior to cancer diagnosis or at anytime after such diagnosis


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age with a histologically confirmed diagnosis of malignant tumor.
* Venous or arterial thromboembolism episode, symptomatic or incidental, in the month prior or any time after the cancer diagnosis and in the three previous months to enrollment, confirmed with an imaging technique: Doppler echocardiography, computed tomography (CT) angiography, etc.
* Signing of informed consent.

Exclusion Criteria:

* Clinical diagnosis of thromboembolic event without radiological confirmation.
* Presenting a single episode of superficial thrombophlebitis without association with another thromboembolic event.
* Each patient will be recorded just once, and therefore a second thromboembolic event will be considered a rethrombosis and will be recorded as such. Patients with a rethrombosis and a previous thromboembolic event before the start of the study in each center will not be able to be included.

Primary outcomes:
measure: Location of origin of the thromboembolytic event
timeFrame: Baseline
measure: Vessel of origin of the thromboembolytic event
timeFrame: Baseline
measure: Thromboembolytic event diagnosis type
timeFrame: Baseline
measure: Primary tumor at the time of the thromboembolic event
timeFrame: Baseline
measure: Tumor-Node-Metastasis classification
timeFrame: Baseline
measure: Time between cancer diagnosis and thromboembolic event
timeFrame: Baseline
measure: Patient situation at the last visit
timeFrame: 12 months
measure: Characteristics of treatment administered for cancer
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios
state: Alicante
city: Elche
country: Spain
facility: Hospital Universitario de Torrevieja
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Català D'Oncologia (ICO) L'Hospitalet
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Taulí
state: Barcelona
city: Sant Joan Despi
country: Spain
facility: Hospital De Sant Joan Despi Moissès Broggi
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Jerez De La Frontera
country: Spain
facility: Hospital de Especialidades de Jerez de la Frontera
state: Cádiz
city: Palma
country: Spain
facility: Hospital Son Espases
state: Islas Baleares
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Univ. de Santiago
state: La Coruña
city: Fuenlabrada
country: Spain
facility: Hospital de Fuenlabrada
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario de Móstoles
state: Madrid
city: Parla
country: Spain
facility: Hospital Infanta Cristina
state: Madrid
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario de A Coruña
city: Alicante
country: Spain
facility: Hospital Universitario San Juan de Alicante
city: Almería
country: Spain
facility: Hospital Univesitario Torrecárdenas
city: Badajoz
country: Spain
facility: Complejo Hospitalario Universitario de Badajoz
city: Barcelona
country: Spain
facility: Hospital Clínic Barcelona
city: Barcelona
country: Spain
facility: Hospital de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Cuenca
country: Spain
facility: Hospital General Virgen de la Luz
city: Cáceres
country: Spain
facility: Hospital Universitario San Pedro de Alcántara
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Gerona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta/Institut Català D'Oncología Girona
city: Jaén
country: Spain
facility: Hospital Universitario de Jaén
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Central de la Defensa Gómez Ulla
city: Madrid
country: Spain
facility: Hospital Fundación Jimenez Díaz
city: Madrid
country: Spain
facility: Hospital MD Anderson Cancer Center Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital Universitario Morales Meseguer
city: San Sebastián De Los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofía
city: Sevilla
country: Spain
facility: Oncoavanze
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
Study officials:
affiliation: Hospital General Universitario Gregorio Marañón, Madrid
name: Andres Muñoz, M.D.
role: STUDY_CHAIR
affiliation: Hospital Universitario y Politécnico La Fe, Valencia
name: José Muñoz Langa, M.D.
role: STUDY_CHAIR
affiliation: Hospital Universitario Morales Meseguer, Murcia
name: Alberto Carmona Bayonas, M.D.
role: STUDY_CHAIR
affiliation: Hospital Universitario Central de Asturias, Oviedo
name: Paula Jiménez Fonseca, M.D.
role: STUDY_CHAIR
affiliation: Hospital Universitario Clínico San Carlos, Madrid
name: Pedro Pérez Segura, M.D.
role: STUDY_CHAIR
affiliation: Hospital Universitario Marqués de Valdecilla, Santander
name: Eva Martínez de Castro, M.D.
role: STUDY_CHAIR
References: