Taiwanese Anaplastic Thyroid Cancer Registry
ConditionThyroid Carcinoma, Anaplastic
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Health Research Institutes, Taiwan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically or cytologically confirmed ATC and diagnosed after 2015.
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.
Disqualifiers
Inability and unwillingness to give informed consent except dead patient.
Patients refuse for collection of clinical data and follow up.
Trial population
Patients who were pathologically or histologically diagnosed as anaplastic thyroid cancer (ATC) are the target population. The ATC may be transformed from DTC or de novo cases. Anticipated 100 patients.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: anaplastic thyroid cancer (ATC)
Trial outcomes
Primary outcomes
1
Enrolled more than 100 anaplastic thyroid cancer patients
100 anaplastic thyroid cancer patients, including denovo ATC or ATC transformed from DTC, or co-existence of ATC and DTC.
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.Secondary outcomes
1
To reported of survival with demographic characteristics, treatment patterns and tumor and blood samples for further biomarker of ATC in Taiwan.
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov
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