Observational Epidemiological Study of Cancer-associated Thrombosis: Registry of Thrombosis & NEoplasia of SEOM (TESEO Study)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Thromboembolism
- Sponsor
- Fundación Sociedad Española de Oncologia Médica
- Enrollment
- 700
- Locations
- 48
- Primary Endpoint
- Characteristics of treatment administered for cancer
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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
Investigators
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.
Outcomes
Primary Outcomes
Characteristics of treatment administered for cancer
Time Frame: 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
Time Frame: Baseline
Distribution in the number of patients according to the anatomical location affected by the thromboembolytic event.
Time between cancer diagnosis and thromboembolic event
Time Frame: Baseline
Based on date on confirmed diagnosis of cancer (primary tumor) and date of thromboembolic event
Patient situation at the last visit
Time Frame: 12 months
Number of patients with rethrombosis, bleeding, other complications, tumor progression or death.
Vessel of origin of the thromboembolytic event
Time Frame: Baseline
Distribution in the number of patients according to the type of vessel affected by the thromboembolytic event.
Thromboembolytic event diagnosis type
Time Frame: Baseline
Proportion of patients with incidental versus symptomatic thormboembolic events
Tumor-Node-Metastasis classification
Time Frame: 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.
Primary tumor at the time of the thromboembolic event
Time Frame: Baseline
Distribution of patients according to the organ affected by the primary tumor.