Registry of Thrombosis & NEoplasia of "Sociedad Española de Oncología Médica"

Cancer Clinical Trial

— TESEO  

Official title:

Observational Epidemiological Study of Cancer-associated Thrombosis: Registry of Thrombosis & NEoplasia of SEOM (TESEO Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03855592
• Other study ID #: SEOM-TESEO-2017-01
• Status: Recruiting
• Start date: July 4, 2018
• Est. completion date: July 2024

Study information

• Verified date: April 2023
• Source: Fundación Sociedad Española de Oncologia Médica
• Contact: Andres Muñoz, M.D.
• Phone: +34 93 434 44 12
• Email: investigacion[@]mfar.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Thromboembolism
• Thrombosis

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de A Coruña	A Coruña
Spain	Hospital Virgen de los Lirios	Alcoy	Alicante
Spain	Hospital Universitario San Juan de Alicante	Alicante
Spain	Hospital Univesitario Torrecárdenas	Almería
Spain	Complejo Hospitalario Universitario de Badajoz	Badajoz
Spain	Hospital Clínic Barcelona	Barcelona
Spain	Hospital de Barcelona	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital de Basurto	Bilbao
Spain	Hospital Universitario San Pedro de Alcántara	Cáceres
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 Universitario de Torrevieja	Elche	Alicante
Spain	Hospital de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitari Dr. Josep Trueta/Institut Català D'Oncología Girona	Gerona
Spain	Hospital Universitario de Jaén	Jaén
Spain	Hospital de Especialidades de Jerez de la Frontera	Jerez De La Frontera	Cádiz
Spain	Institut Català D'Oncologia (ICO) L'Hospitalet	L'Hospitalet De Llobregat	Barcelona
Spain	Hospital Universitario Insular de Gran Canaria	Las Palmas De Gran Canaria
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital Central de la Defensa Gómez Ulla	Madrid
Spain	Hospital Fundación Jimenez Díaz	Madrid
Spain	Hospital MD Anderson Cancer Center Madrid	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Clínico San Carlos	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario la Princesa	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario de Móstoles	Móstoles	Madrid
Spain	Hospital Universitario Morales Meseguer	Murcia
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Son Espases	Palma	Islas Baleares
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Infanta Cristina	Parla	Madrid
Spain	Hospital Universitari Parc Taulí	Sabadell	Barcelona
Spain	Hospital Universitario Infanta Sofía	San Sebastián De Los Reyes
Spain	Hospital De Sant Joan Despi Moissès Broggi	Sant Joan Despi	Barcelona
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Complejo Hospitalario Univ. de Santiago	Santiago de Compostela	La Coruña
Spain	Oncoavanze	Sevilla
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politècnic La Fe	Valencia
Spain	Hospital Álvaro Cunqueiro	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Sociedad Española de Oncologia Médica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Location of origin of the thromboembolytic event	Distribution in the number of patients according to the anatomical location affected by the thromboembolytic event.	Baseline
Primary	Vessel of origin of the thromboembolytic event	Distribution in the number of patients according to the type of vessel affected by the thromboembolytic event.	Baseline
Primary	Thromboembolytic event diagnosis type	Proportion of patients with incidental versus symptomatic thormboembolic events	Baseline
Primary	Primary tumor at the time of the thromboembolic event	Distribution of patients according to the organ affected by the primary tumor.	Baseline
Primary	Tumor-Node-Metastasis classification	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.	Baseline
Primary	Time between cancer diagnosis and thromboembolic event	Based on date on confirmed diagnosis of cancer (primary tumor) and date of thromboembolic event	Baseline
Primary	Patient situation at the last visit	Number of patients with rethrombosis, bleeding, other complications, tumor progression or death.	12 months
Primary	Characteristics of treatment administered for cancer	Based on the number of patients prescribed with chemotherapy, radiation therapy, hormonal therapy, erythropoietin, transfusions, surgery, catheter, etc.	Baseline