Medical Oncology Department, Hospital Clínico Universitario de Valencia, Avinguda Blasco Ibáñez nº 17, Valencia, 46010, Spain.
Medical Oncology Department, Hospital Universitario Central de Asturias, ISPA, Oviedo, Spain.
Clin Transl Oncol. 2021 Apr;23(4):799-811. doi: 10.1007/s12094-020-02472-x. Epub 2020 Aug 13.
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.
After 18 months and with 35 centers and researchers, the registry has 1128 patients.
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.
血栓栓塞并发症是癌症患者中一种严重、可预防且常见的事件，会导致发病率和死亡率上升。尽管人们对癌症相关血栓形成（CAT）有了更多的了解，但在诊断、临床管理、治疗和预后方面仍有几个方面存在不确定性，这些方面在随机临床试验中代表性不足。出于这个原因，西班牙肿瘤内科学会（SEOM）于 2018 年 6 月启动了 CAT 登记处。
方法/设计：TESEO 是一项正在进行的前瞻性、非干预性、多中心研究，纳入了新诊断为血栓栓塞事件（TEE）的连续癌症患者。入选标准包括年龄>18 岁，组织学证实患有癌症，且在过去一个月或癌症诊断后任何时间通过影像学技术确诊有症状或偶发性 TEE，并签署知情同意书。该研究由两个独立但相互关联的前瞻性登记处组成。常规 CAT 子登记处包括患者癌症特征、提供的抗凝治疗和结局数据的信息。特殊 CAT 子登记处包括与 CAT 特殊情况相关的变量，包括严重肾衰竭、血小板减少症、与癌症相关的高出血风险以及出血和接受新治疗（如靶向治疗、抗血管生成药物和免疫疗法）共存的患者。该登记处考虑癌症的状态和时间，以评估血栓形成发生时预后的变化。一些结局，如再血栓形成、大出血、肿瘤进展和生存，将在不同的时间间隔内进行评估，包括事件发生后 1、3、6 和 12 个月；然后每 6 个月评估一次，直到患者死亡。
经过 18 个月，有 35 个中心和研究人员参与，该登记处已有 1128 名患者。
TESEO 登记处将为不同情况下的 CAT 预防、治疗和并发症提供临床真实世界证据，这些情况在随机临床试验中代表性不足。
