Taiwanese Anaplastic Thyroid Cancer Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Enrolled more than 100 anaplastic thyroid cancer patients
研究概览
简要总结
Primary treatment strategies for ATC have included surgical resection combined with radiotherapy, chemotherapy, or concurrent chemoradiation therapy. Despite these aggressive approaches, disease recurrence or progression remains frequently observed. Recent advances in molecular diagnostics and targeted therapy development have expanded treatment options for ATC patients with actionable genetic alterations, such as BRAF mutations or NTRK fusions. Nevertheless, for patients lacking identifiable targetable mutations, therapeutic options remain limited and clinical outcomes are poor. To address this unmet clinical need, the investigators aim to analyze baseline characteristics, treatment outcomes, and biomarker profiles from a larger cohort of ATC patients, with the goal of identification of predictive biomarkers and potential therapeutic targets. Given the rarity of ATC, conducting comprehensive studies at a single institution is challenging. Therefore, the investigators propose to establish a multi-center registry to systematically collect clinical data and tumor specimens from ATC patients.
详细描述
Thyroid cancers are pathologically classified into differentiated thyroid cancer (DTC),medullary (MTC) and anaplastic carcinoma (ATC). ATC accounts for approximately 1% of thyroid cancer cases in Taiwan and is characterized by its aggressive clinical course with extremely poor prognosis. A subset of patients may present with mixed histology, exhibiting both DTC and ATC components, or may experience progression from DTC to ATC. These cases are typically associated with rapid disease progression and significantly worse clinical outcomes. Because the incidence of ATC is very low, it is not easy to conduct clinical trials with large sample size to investigate novel treatment strategies with some effective treatment modalities reported by case reports or case series. Recently, the genetic test has been reimbursed by our health Bureau for ATC cases. In this study, the investigators aim to enroll ATC patients from multi-centers in Taiwan to collect the baseline characteristics, genetic data, treatment patterns, and clinical outcome of the ATC patients. In addition, the investigators want to collect tumor and blood samples for ATC patients to explore the biomarkers and potential treatment modalities from the real-world data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically or cytologically confirmed ATC and diagnosed after
- •Capable of understanding and complying with the protocol requirements and signed informed consent. The dead patient can be enrolled without signed informed consent and they were dead before 2025.6.30.
排除标准
- •Inability and unwillingness to give informed consent except dead patient.
- •Patients refuse for collection of clinical data and follow up.
结局指标
主要结局
Enrolled more than 100 anaplastic thyroid cancer patients
时间窗: Pathologically or cytologically confirmed ATC and diagnosed after 2015，The dead patient can be enrolled without signed informed consent and they were dead before 2025.6.30.
100 anaplastic thyroid cancer patients, including denovo ATC or ATC transformed from DTC, or co-existence of ATC and DTC.
次要结局
- To reported of survival with demographic characteristics, treatment patterns and tumor and blood samples for further biomarker of ATC in Taiwan.(After registration. The clinical data of treatment, treatment response, treatment toxicities, and survival of the enrolled patients after enrollment will be collected every 3 months. Followed up for the survival till 3 years.)