NCT Number: NCT07138261
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Taipei Veterans General Hospital, Taipei, Taiwan/Taipei, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Patients with histologically or cytologically diagnosed anaplastic thyroid cancer are eligible. Eligible patients will be enrolled to collect the clinical data,genetic data, treatment and outcomes of the patients, and blood and archived tumor samples. The clinical data include baseline characteristics, diagnosis,stage, prior and current treatment, and treatment outcome (response, toxicities and survival). The genetic data includes any genetic data performed by IHC,sanger sequencing or NGS-based oncopanel or other approaches. The archived tumor sample will be collected for further biomarker study. A blood sample will also be collected for germline mutation analysis. The clinical and genetic data collected in this trial will be stored in the Clinical Trial Information Management System (CTIMeS) of Taiwan Cooperative Oncology Group (TCOG) for further analysis.
Contact information is provided by the study sponsor or research team.
Chien-Ya Hung Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, B.S.N.
CONTACT
+886-3-7206166 ext. 65112
Wei-Lien Feng Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, M.S.N.
CONTACT
+886-02-26534401 ext. 21012
National Health Research Institutes, Taiwan
Other
Acronym: TATC
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