Registry of Thrombosis & NEoplasia of Sociedad Española de Oncología Médica

Study Overview
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Brief Summary
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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

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

Conditions
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Thromboembolism, Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location of origin of the thromboembolytic event | Distribution in the number of patients according to the anatomical location affected by the thromboembolytic event. | Baseline | 
| 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 | 
| Thromboembolytic event diagnosis type | Proportion of patients with incidental versus symptomatic thormboembolic events | Baseline | 
| Primary tumor at the time of the thromboembolic event | Distribution of patients according to the organ affected by the primary tumor. | Baseline | 
| 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 | 
| Time between cancer diagnosis and thromboembolic event | Based on date on confirmed diagnosis of cancer (primary tumor) and date of thromboembolic event | Baseline | 
| Patient situation at the last visit | Number of patients with rethrombosis, bleeding, other complications, tumor progression or death. | 12 months | 
| 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 |