Taiwanese Anaplastic Thyroid Cancer Registry

NCT07138261 | Not Yet Recruiting DMC

• 1 other identifier: T1325
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 9

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.

Conditions

Thyroid Carcinoma, Anaplastic

Keywords

Anaplastic thyroid cancer; Genetic aberrations in anaplastic thyroid cancer; Treatment for anaplastic thyroid cancer

Outcome Measures

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.

  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.

  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.

Study Arms (1)

anaplastic thyroid cancer (ATC)

Pathologically or cytologically confirmed ATC and diagnosed after 2015.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (9)

Taipei Veterans General Hospital

Taipei, Taiwan/Taipei, Taiwan

Location

Kaohsiung Medical University

Kaohsiung City, Taiwan

Location

National Taiwan University Hospital ,NTUH Hsin-Chu Branch

Sindian City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

CHANG GUNG MEMORIAL HOSPITAL, Linkou

Taoyuan District, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 23130564 BACKGROUND

• 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.

  PMID: 26462967 BACKGROUND

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

The archived tumor sample of FFPE blocks derived from biopsy or surgery is applied from each hospital. For each tumor sample, 10 slices of 4um are needed with 3 put in non-coated slides and 7 in coated slides. Another 10 slides of 4um of non-coated slides will be collected for NGS-based study if there is other funding support available.

MeSH Terms

Conditions

Thyroid Carcinoma, Anaplastic

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

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

  Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan

  STUDY CHAIR

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

  Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+886-02-26534401; winnif@nhri.edu.tw

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

CONTACT

+886-3-7206166; 951106@nhri.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2035
• Study Completion (Estimated): December 30, 2035
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

TW (9)