Registry of Thrombosis & NEoplasia of "Sociedad Española de Oncología Médica"
- Conditions
- ThromboembolismCancer
- Registration Number
- NCT03855592
- Lead Sponsor
- Fundación Sociedad Española de Oncologia Médica
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 700
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Characteristics of treatment administered for cancer Baseline Based on the number of patients prescribed with chemotherapy, radiation therapy, hormonal therapy, erythropoietin, transfusions, surgery, catheter, etc.
Location of origin of the thromboembolytic event Baseline Distribution in the number of patients according to the anatomical location affected by the thromboembolytic event.
Time between cancer diagnosis and thromboembolic event Baseline Based on date on confirmed diagnosis of cancer (primary tumor) and date of thromboembolic event
Vessel of origin of the thromboembolytic event Baseline Distribution in the number of patients according to the type of vessel affected by the thromboembolytic event.
Thromboembolytic event diagnosis type Baseline Proportion of patients with incidental versus symptomatic thormboembolic events
Tumor-Node-Metastasis classification Baseline Based on the American Joint Committee on Cancer 2018 Tumor-Node-Metastasis classification system: T for extent or size of the tumor, N for lymph nodes spread and M for metastasis.
Patient situation at the last visit 12 months Number of patients with rethrombosis, bleeding, other complications, tumor progression or death.
Primary tumor at the time of the thromboembolic event Baseline Distribution of patients according to the organ affected by the primary tumor.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (48)
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario de Móstoles
🇪🇸Móstoles, Madrid, Spain
Hospital MD Anderson Cancer Center Madrid
🇪🇸Madrid, Spain
Hospital Universitario de Torrevieja
🇪🇸Elche, Alicante, Spain
Hospital Virgen de los Lirios
🇪🇸Alcoy, Alicante, Spain
Institut Català D'Oncologia (ICO) L'Hospitalet
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Universitari Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Son Espases
🇪🇸Palma, Islas Baleares, Spain
Hospital de Especialidades de Jerez de la Frontera
🇪🇸Jerez De La Frontera, Cádiz, Spain
Hospital De Sant Joan Despi Moissès Broggi
🇪🇸Sant Joan Despi, Barcelona, Spain
Hospital de Fuenlabrada
🇪🇸Fuenlabrada, Madrid, Spain
Complejo Hospitalario Univ. de Santiago
🇪🇸Santiago de Compostela, La Coruña, Spain
Hospital Infanta Cristina
🇪🇸Parla, Madrid, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Complejo Hospitalario Universitario de A Coruña
🇪🇸A Coruña, Spain
Hospital Universitario San Juan de Alicante
🇪🇸Alicante, Spain
Hospital Clínic Barcelona
🇪🇸Barcelona, Spain
Complejo Hospitalario Universitario de Badajoz
🇪🇸Badajoz, Spain
Hospital Univesitario Torrecárdenas
🇪🇸Almería, Spain
Hospital de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de Basurto
🇪🇸Bilbao, Spain
Hospital General Universitario de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital General Virgen de la Luz
🇪🇸Cuenca, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Spain
Hospital Universitari Dr. Josep Trueta/Institut Català D'Oncología Girona
🇪🇸Gerona, Spain
Hospital Universitario San Pedro de Alcántara
🇪🇸Cáceres, Spain
Hospital Universitario de Jaén
🇪🇸Jaén, Spain
Hospital Universitario Insular de Gran Canaria
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital Universitario Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Infanta Sofía
🇪🇸San Sebastián De Los Reyes, Spain
Consorcio Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Oncoavanze
🇪🇸Sevilla, Spain
Hospital Universitario Morales Meseguer
🇪🇸Murcia, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Spain
Hospital Central de la Defensa Gómez Ulla
🇪🇸Madrid, Spain
Hospital Fundación Jimenez Díaz
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario la Princesa
🇪🇸Madrid, Spain