Thyroid Carcinoma, AnaplasticTATCNCT07138261
Taiwanese Anaplastic Thyroid Cancer Registry
An observational study of Thyroid Carcinoma, Anaplastic, run by National Health Research Institutes, Taiwan at 9 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Carcinoma, Anaplastic
- How many people
- 100 participants
- Where
- 9 sitesTaiwan
- Study dates
- 1 Sep 2025to 30 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Inability and unwillingness to give informed consent except dead patient.
- Patients refuse for collection of clinical data and follow up.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Wei-Lien Feng Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, M.S.N. contact
Chien-Ya Hung Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, B.S.N. contact
9 sites in 1 country
Taiwan9 sites
Kaohsiung Medical University
Kaohsiung City
Jeng-Shiun Du
National Taiwan University Hospital ,NTUH Hsin-Chu Branch
Sindian City
Jih-Hsiang Lee
China Medical University Hospital
Taichung
Chen-Yuan Lin
National Cheng Kung University Hospital
Tainan
Hui-Jen Tsai, MD, PhD
Taipei Veterans General Hospital
Taipei, Taiwan/Taipei
Chun-Yu Liu
Koo Foundation Sun Yat-Sen Cancer Center
Taipei
Kuo-Chen Huang
National Taiwan University Hospital
Taipei
Jih-Hsiang Lee
Tri-Service General Hospital
Taipei
Jen-Hua Yeh
CHANG GUNG MEMORIAL HOSPITAL, Linkou
Taoyuan
Chiao En Wu, MD, PhD
About this study
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.
Read the 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
- Keywords
- Anaplastic thyroid cancer, Genetic aberrations in anaplastic thyroid cancer, Treatment for anaplastic thyroid cancer
- Medical subject headings
- Thyroid Carcinoma, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| anaplastic thyroid cancer (ATC) | Pathologically or cytologically confirmed ATC and diagnosed after 2015. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Dec 2035 (estimated)
- Study completion30 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid Carcinoma, AnaplasticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsang-Wu Liu Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, M.D. PhD, Study chair, Taiwan Cooperative Oncology Group,NHRI,Taipei, TaiwanHui-Jen Tsai Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, M.D. PhD, Principal investigator, Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138261
- Sponsor's protocol ID
- T1325
- Acronym
- TATC
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23130564Haugen 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.
PubMed 26462967
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwanese Anaplastic Thyroid Cancer Registry
- ClinicalTrials.gov ID
- NCT07138261
- Acronym / sponsor ID
- TATC / T1325
- Conditions
- Thyroid Carcinoma, Anaplastic
- Keywords
- Anaplastic thyroid cancer, Genetic aberrations in anaplastic thyroid cancer, Treatment for anaplastic thyroid cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2035 (estimated)
- Study completion
- 30 Dec 2035 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anaplastic thyroid cancer (ATC) | – | –Pathologically or cytologically confirmed ATC and diagnosed after 2015. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability and unwillingness to give informed consent except dead patient.
- Patients refuse for collection of clinical data and follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Enrolled more than 100 anaplastic thyroid cancer patients
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.
1 secondary outcome
To reported of survival with demographic characteristics, treatment patterns and tumor and blood samples for further biomarker of ATC in Taiwan.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 23130564Smallridge 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.
- Background: PubMed 26462967Haugen 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.
- Cancer Registry Annual Report, 2022 Taiwan. Health Promotion Administration Ministry of Health and WelfareLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei-Lien Feng Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, M.S.N. contact
Chien-Ya Hung Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, B.S.N. contact
Tsang-Wu Liu Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, M.D. PhD study chair
Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan
Hui-Jen Tsai Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, M.D. PhD principal investigator
Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Carcinoma, Anaplastic, run by National Health Research Institutes, Taiwan at 9 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei-Lien Feng Taiwan Cooperative Oncology Group,NHRI,Taipei, Taiwan, M.S.N. (+886-02-26534401 ext. 21012, winnif@nhri.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrolled more than 100 anaplastic thyroid cancer patients (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07138261, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.