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NCT Number: NCT03855592

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

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

Recruiting

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Key information

Conditions

Thromboembolism Cancer Cardiovascular Diseases Embolism and Thrombosis Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Virgen de los Lirios, Alcoy, Alicante, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Thromboembolytic event diagnosis type

    Time frame: Baseline

    Proportion of patients with incidental versus symptomatic thormboembolic events

  4. Primary tumor at the time of the thromboembolic event

    Time frame: Baseline

    Distribution of patients according to the organ affected by the primary tumor.

  5. 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.

  6. 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

  7. Patient situation at the last visit

    Time frame: 12 months

    Number of patients with rethrombosis, bleeding, other complications, tumor progression or death.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andres Muñoz, M.D.

CONTACT

[email protected]

+34 93 434 44 12

Federico Nepote

CONTACT

[email protected]

+34 93 434 44 12

Sponsors and collaborators

Lead sponsor

Fundación Sociedad Española de Oncologia Médica

Other

Registry information

Official study title

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

Acronym: TESEO

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2019
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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