Rationale, design and methodology of TESEO study: a registry of thrombosis and neoplasia of SEOM (Spanish Society of Medical Oncology)

• J. Muñoz-Langa ^[1] ; P. Jimenez-Fonseca ^[2] ; A. Carmona-Bayonas ^[15] ; E.M. de Castro ^[3] ; P. Pérez-Segura ^[4] ; M.S. Cánovas ^[15] ; D. Gomez ^[2] ; L.O. Moran ^[16] ; M.B.G. de Tejada ^[17] ; E. Seguí ^[18] ; G.B. López ^[5] ; S.G. Adrián ^[6] ; M.C. Campos ^[7] ; V.P. Olmos ^[8] ; B.O. Portero ^[9] ; M.S. Moyano ^[19] ; J.A.S. Crespo ^[10] ; L.T. Sánchez ^[20] ; M.A. Rebollo ^[11] ; P.O. Rivas ^[12] ; J.P. Altozano ^[13] ; Á.R. Lescure ^[14] ; A. Muñoz-Martín ^[16]
  1. [1] Hospital Clinico Universitario de Valencia

     Hospital Clinico Universitario de Valencia

     Valencia, España

     
  2. [2] Hospital Universitario Central de Asturias

     Hospital Universitario Central de Asturias

     Oviedo, España

     
  3. [3] Hospital Universitario Marqués de Valdecilla

     Hospital Universitario Marqués de Valdecilla

     Santander, España

     
  4. [4] Hospital Clínico San Carlos de Madrid

     Hospital Clínico San Carlos de Madrid

     Madrid, España

     
  5. [5] Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias

     Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias

     Gran Canaria, España

     
  6. [6] Hospital de Móstoles

     Hospital de Móstoles

     Móstoles, España

     
  7. [7] Hospital Universitario Lucus Augusti

     Hospital Universitario Lucus Augusti

     Lugo, España

     
  8. [8] Hospital Ramón y Cajal

     Hospital Ramón y Cajal

     Madrid, España

     
  9. [9] Hospital Infanta Leonor

     Hospital Infanta Leonor

     Madrid, España

     
  10. [10] Hospital Virgen de La Luz de Cuenca

      Hospital Virgen de La Luz de Cuenca

      Cuenca, España

      
  11. [11] Institute Catalá Oncología

      Institute Catalá Oncología

      Barcelona, España

      
  12. [12] Hospital Central de la Defensa

      Hospital Central de la Defensa

      Madrid, España

      
  13. [13] Hospital Virgen de los Lirios

      Hospital Virgen de los Lirios

      Alcoy, España

      
  14. [14] Hospital General Universitario de Elche

      Hospital General Universitario de Elche

      Elche, España

      
  15. [15] Hematology and Medical Oncology Department, Hospital Universitario Morales Meseguer, University of Murcia
  16. [16] Medical Oncology Department, Hospital Universitario Gregorio Marañón, Madrid
  17. [17] Medical Oncology Department, Hospital Universitario Val d´Hebron, Barcelona
  18. [18] Medical Oncology Department, Hospital Universitario Santa Creu i Sant Pau, Barcelona
  19. [19] Medical Oncology Department, Hospital Universitario de Jerez de la Frontera, Cádiz,
  20. [20] Medical Oncology Department, Complejo Hospitalario de Navarra, Pamplona

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• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 23, Nº. 4, 2021, págs. 799-811
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • Background and rationale Thromboembolic complications are a serious, preventable and common event in cancer patients that contributes to increasing morbidity and mortality. Despite increasing knowledge on cancer-associated thrombosis (CAT), there are still several aspects of diagnosis, clinical management, treatment and prognosis with uncertainties that are under-represented in randomized clinical trials. For this reason, the Spanish Society of Medical Oncology (SEOM) launched in June 2018 a registry of CAT.

    Methods/design TESEO is an ongoing prospective, non-interventional, multicentric study in consecutive cancer patients with newly diagnosed of thromboembolic event (TEE). Eligibility criteria include being  > 18 years with a histologically confirmed diagnosis of cancer and a symptomatic or incidental TEE confirmed with an imaging technique in the previous month or any time after the cancer diagnosis and signing of informed consent. The study consists of two types of integrated but independent prospective registries. Regular CAT sub-registry includes information on patient’s cancer´s characteristics, anticoagulant treatment provided and outcome data. Special CAT sub-registry includes variables related to special situations of CAT that comprise patients with severe kidney failure, thrombocytopenia, high risk of bleeding related to the cancer or with coexistence of bleeding and patients who receive new treatments such a targeted therapy, antiangiogenics agents and immunotherapy. The registry considers the status of the cancer and the time to assess how the prognosis is changed based on when the thrombus occurs. Some outcomes such as rethrombosis, major bleeding, tumor progression and survival will be valued in various time intervals including 1, 3, 6 and 12 months after the even in the first year; and then every 6 months until the patient’s death.

    Results After 18 months and with 35 centers and researchers, the registry has 1128 patients.

    Conclusion TESEO registry will provide clinical real-world evidence for prevention, treatment and complications of CAT in different scenarios that are under-represented in randomized clinical trials.