Taiwanese Anaplastic Thyroid Cancer Registry

Not yet recruiting

• Conditions: Thyroid Carcinoma, Anaplastic

• Registration Number: NCT07138261
• Lead Sponsor: National Health Research Institutes, Taiwan

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-03
• Study First Submitted QC: 2025-08-17
• Last Update Submitted: 2025-08-17
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Study Start: 2025-09-01
• Primary Completion: 2035-12-30
• Study Completion: 2035-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Pathologically or cytologically confirmed ATC and diagnosed after 2015.
2. 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.

Exclusion Criteria

1. Inability and unwillingness to give informed consent except dead patient.
2. Patients refuse for collection of clinical data and follow up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Enrolled more than 100 anaplastic thyroid cancer patients	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (9)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan/Taipei, Taiwan

Kaohsiung Medical University; 🇨🇳 Kaohsiung city, Taiwan

National Taiwan University Hospital ,NTUH Hsin-Chu Branch; 🇨🇳 Sindian City, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan

CHANG GUNG MEMORIAL HOSPITAL, Linkou; 🇨🇳 Taoyuan, Taiwan