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

Clinical and Translational Oncology volume 23, pages 799–811 (2021)Cite this article

Abstract

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.

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Acknowledgements

SEOM for sponsoring this study and generating the necessary network for this collaborative work. The mFAR team for the support of the website registry.

Funding

The study has been funded by a restricted grant from Sanofi, S.A. This entity has not contributed to the study design, data analysis, interpretation of the results, drafting of the document, or in the decision regarding publication in any way.

Author information

Affiliations

  1. Medical Oncology Department, Hospital Clínico Universitario de Valencia, Avinguda Blasco Ibáñez nº 17, Valencia, 46010, Spain

    J. Muñoz-Langa

  2. Medical Oncology Department, Hospital Universitario Central de Asturias, ISPA, Oviedo, Spain

    P. Jimenez-Fonseca & D. Gomez

  3. Hematology and Medical Oncology Department, Hospital Universitario Morales Meseguer, University of Murcia, IMIB, Murcia, Spain

    A. Carmona-Bayonas & M. S. Cánovas

  4. Medical Oncology Department, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain

    E. M. de Castro

  5. Medical Oncology Department, Hospital Universitario Clínico San Carlos, Madrid, Spain

    P. Pérez-Segura

  6. Medical Oncology Department, Hospital Universitario Gregorio Marañón, Madrid, Spain

    L. O. Moran & A. Muñoz-Martín

  7. Medical Oncology Department, Hospital Universitario Val d´Hebron, Barcelona, Spain

    M. B G. de Tejada

  8. Medical Oncology Department, Hospital Universitario Santa Creu i Sant Pau, Barcelona, Spain

    E. Seguí

  9. Medical Oncology Department, Hospital Universitario Insular de Gran Canaria, Tenerife, Spain

    G. B. López

  10. Medical Oncology Department, Hospital Universitario de Móstoles, Madrid, Spain

    S. G. Adrián

  11. Medical Oncology Department, Hospital Universitario Lucus Augusti, Lugo, Spain

    M. C. Campos

  12. Medical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain

    V. P. Olmos

  13. Medical Oncology Department, Hospital Universitario Infanta Leonor, Madrid, Spain

    B. O. Portero

  14. Medical Oncology Department, Hospital Universitario de Jerez de la Frontera, Cádiz, Spain

    M. S. Moyano

  15. Medical Oncology Department, Hospital Virgen de la Luz, Cuenca, Spain

    J. A. S. Crespo

  16. Medical Oncology Department, Complejo Hospitalario de Navarra, Pamplona, Spain

    L. T. Sánchez

  17. Medical Oncology Department, Institut Català D’Oncologia (ICO), L’Hospitalet, Barcelona, Spain

    M. A. Rebollo

  18. Medical Oncology Department, Hospital Central de la Defensa Gomez Ulla, Madrid, Spain

    P. O. Rivas

  19. Medical Oncology Department, Hospital Virgen de los Lirios, Alcoy, Alicante, Spain

    J. P. Altozano

  20. Medical Oncology Department, Hospital General Universitario de Elche, Elche, Spain

    Á. R. Lescure

Authors
  1. J. Muñoz-Langa
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  2. P. Jimenez-Fonseca
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  6. M. S. Cánovas
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  7. D. Gomez
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Contributions

JML, AMM, ACB, PJF, EMC and PPS developed the project. JML drafted the manuscript. The rest of the authors have participated in the revision and correction the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to J. Muñoz-Langa.

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Conflict of interest

JML: consultant or Advisory Role: LEO Pharma. Sanofi. Rovi. Speaking: Sanofi, LeoPharma, Rovi. Travel, Accommodations: LeoPharma, Sanofi. PJF: consultant or advisory role: Roche, Bristol, Mylan, Rovi, Sanofi, LeoPharma; travel grants: Ipsen. ACB: consultant or advisory role: Roche, Rovi, Sanofi, LeoPharma, Pfizer, Esteve; travel grants: Ipsen, Roche, Novartis. EMC: consultant or Advisory Role: Pfizer, Amgen. Speaking: Roche, Pfizer, Amgen, Sanofi, LeoPharma, Rovi, Celgene. Travel, Accommodations: Roche, Pfizer, Celgene, Sanofi. PPS: consultant or Advisory Role: Novartis, BMS, Merck. Travel, Accommodations: MSD, Merck. MSC: consultant or Advisory Role: KyowaKirin. Research Funding: LeoPharma. Financial support for educational programs: Angelini, Sanofi, Rovi, LeoPharma, Servier. Remunerations for authorship: KyowaKirin, Mylan. Travel, Accommodations: Sanofi, MSD, Esteve, Amgen, Servier, Angelini, Leo Pharma. DG: None. LOM: consultant or Advisory Role: Sanofi. Speaking: Amgen, Sanofi, Leo-Pharma. Travel, Accommodations: Roche, Amgen, Sanofi, LeoPharma. MBGT: Speaker: Rovi, Leo Pharma, Sanofi, Sponsored Academic Activities: Rovi, Leo Pharma. ES: None. GBL: None. SGA: consultant/advisory honorarium Eisai, Celgene, Roche, Pierre Fabre, Novartis, Sanofi Aventis and Astra Zeneca. MCC: consultant/advisory Role: Leo pharma. Speaking: Rovi. VPO: Advisory board: Daichi. Speaking: Sanofi, Leo-Pharma. BOP: none. MSM: none. JASC: advisory board; Sanofi, Servier. LTS: none. MAR: none. POR: none. JPA: none ARL: Consultant or Advisory Role: Roche, Pfizer, Novartis, Lilly, Mylan. Speaking: Roche, Pfizer, Novartis, Lilly, Kern, A-Z, Mylan, Eisai. Travel, Accommodations (ASCO, SABCS): Roche, Novartis. Research Funding To my Institution: Roche, Novartis, Pfizer, Lilly, Astra-Zeneca, Amgen, MSD. AM: consulting, lectures and advisory board: Sanofi, Celgene, Astra-Zeneca, Roche, Leo Pharma, Servier, Pfizer, Bristol-Myers Squibb, Daiichi Sankyo, Bayer, Halozyme, Amgen, Rovi, Merck Sharp & Dohme and Lilly. Research funding: Sanofi, LEO Pharma, Celgene. Travel, Accommodations: Roche, Merck Serono, Amgen, Celgene. All outside of the scope of this work.

Research involving human participants

All procedures followed are in accordance with the ethical standards of the committee in charge of human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions.

Informed consent

was obtained from all patients before they were included in the study.

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Muñoz-Langa, J., Jimenez-Fonseca, P., Carmona-Bayonas, A. et al. Rationale, design and methodology of TESEO study: a registry of thrombosis and neoplasia of SEOM (Spanish Society of Medical Oncology). Clin Transl Oncol 23, 799–811 (2021). https://doi.org/10.1007/s12094-020-02472-x

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Keywords

  • Registry
  • Real-world evidence
  • Cancer-associated thrombosis (CAT)
  • Venous thromboembolism
  • Pulmonary embolism
  • Deep vein thrombosis
  • Anticoagulation