Taiwanese Anaplastic Thyroid Cancer Registry

NCT ID: NCT07138261

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2035-12-30

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.

Conditions

Thyroid Carcinoma, Anaplastic

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

anaplastic thyroid cancer (ATC)

Pathologically or cytologically confirmed ATC and diagnosed after 2015.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsang-Wu Liu Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, M.D. PhD

Role: STUDY_CHAIR

Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan

Hui-Jen Tsai Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, M.D. PhD

Role: PRINCIPAL_INVESTIGATOR

Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan

Locations

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 City, , 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 District, , Taiwan

Countries

Taiwan

Central Contacts

Wei-Lien Feng Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, M.S.N.

Role: CONTACT

winnif@nhri.edu.tw

+886-02-26534401 ext. 21012

Chien-Ya Hung Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, B.S.N.

Role: CONTACT

951106@nhri.edu.tw

+886-3-7206166 ext. 65112

Facility Contacts

Chun-Yu Liu

Role: primary

Jeng-Shiun Du

Role: primary

Jih-Hsiang Lee

Role: primary

Chen-Yuan Lin

Role: primary

Hui-Jen Tsai, MD, PhD

Role: primary

Kuo-Chen Huang

Role: primary

Jih-Hsiang Lee

Role: primary

Jen-Hua Yeh

Role: primary

Chiao En Wu, MD, PhD

Role: primary

References

Smallridge RC, Ain KB, Asa SL, Bible KC, Brierley JD, Burman KD, Kebebew E, Lee NY, Nikiforov YE, Rosenthal MS, Shah MH, Shaha AR, Tuttle RM; American Thyroid Association Anaplastic Thyroid Cancer Guidelines Taskforce. American Thyroid Association guidelines for management of patients with anaplastic thyroid cancer. Thyroid. 2012 Nov;22(11):1104-39. doi: 10.1089/thy.2012.0302.

Reference Type: BACKGROUND

PMID: 23130564 (View on PubMed)

Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.

Reference Type: BACKGROUND

PMID: 26462967 (View on PubMed)

Related Links

https://www.hpa.gov.tw/EngPages/Detail.aspx?nodeid=1070&pid=16384

Cancer Registry Annual Report, 2022 Taiwan. Health Promotion Administration Ministry of Health and Welfare

Other Identifiers

T1325

Identifier Type: -

Identifier Source: org_study_id