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Recruiting NCT03855592

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

Observational Thromboembolism Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Thromboembolism, Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Primary outcome measures

  • Location of origin of the thromboembolytic event [Time frame: Baseline]
  • Vessel of origin of the thromboembolytic event [Time frame: Baseline]
  • Thromboembolytic event diagnosis type [Time frame: Baseline]
  • Primary tumor at the time of the thromboembolic event [Time frame: Baseline]
  • Tumor-Node-Metastasis classification [Time frame: Baseline]
  • Time between cancer diagnosis and thromboembolic event [Time frame: Baseline]
  • Patient situation at the last visit [Time frame: 12 months]
  • Characteristics of treatment administered for cancer [Time frame: Baseline]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Spain · 48 centers
  • Hospital Virgen de los Lirios — Alcoy
  • Hospital Universitario de Torrevieja — Elche
  • Hospital Son Espases — Palma
  • Institut Català D'Oncologia (ICO) L'Hospitalet — L'Hospitalet de Llobregat
  • Hospital Universitari Parc Taulí — Sabadell
  • Hospital De Sant Joan Despi Moissès Broggi — Sant Joan Despí
  • Hospital Universitario Marqués de Valdecilla — Santander
  • Hospital de Especialidades de Jerez de la Frontera — Jerez de la Frontera
  • … and 40 more centers

Identifiers

NCT: NCT03855592 · SEOM-TESEO-2017-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗