Thyroid CancerNCT05541380
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients (TOPICS-THYROID)
An observational study of Thyroid Cancer, run by National Health Research Institutes, Taiwan at 9 sites in Taiwan.
Trial summary
Because one cancer type may harbor various genetic aberrations, it is not enough to check only one or a few genes for a patient to choose the adequate treatment. Because the advance in multiplex genomic testing, several NGS-based cancer-associated genetic panel tests (oncopanel) have been developed and used to… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients
- How many people
- 300 participants
- Where
- 9 sitesTaiwan
- Study dates
- 29 Aug 2022to 31 Dec 2030
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We plan to include 250 advanced thyroid cancer patients, including 150 papillary thyroid cancer cancers (cohort A), and 50 non-PTC DTC, including follicular thyroid cancers, Hurthle cell carcinoma and poorly-differentiated carcinoma (cohort B), 25 medullary thyroid cancer (cohort C), and 25 anaplastic thyroid cancer (cohort D) in this study. There is no case number limitation for cohort E. However, we estimate to enroll approximately 50 patients in cohort E. In cohort A, the enrolled number of men and women must be ≥ 50 for each group.
Who may be able to join
- Cohort A:
- Pathologically confirmed papillary thyroid carcinoma (PTC).
- The patient is in advanced stage, which includes recurrent, metastatic, unresectable, or persistent disease.
- The patients are RAI-refractory* or ineligible for RAI therapy**.
- The definitions of RAI-refractory are one of the following criteria: no uptake of RAI in the tumor, uptake of RAI in some tumors but no uptake in other tumors, disease progression in spite of RAI uptake in the tumors, or accumulated RAI dose ≥ 600 mCi.
- the definitions of ineligible for RAI therapy are one of the following criteria: patients are unable to have RAI therapy due to some reasons, such as not received total thyroidectomy, unable to receive total thyroidectomy, or unable to have self-care in the isolation room.
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- The patient needs systemic therapy.
- There are archived tumor samples available and the date of archived tumor sampling must be not more than 5 years from screening date. If there is no archived tumor sample available or the tumor sampling date is more than 5 years from screening date, re-biopsy is needed. If the quality of tumor sample is not fit for NGS oncopanel test, re-biopsy is needed.
- Age ≥ the legal age.
- Life expectancy greater than 6 months.
- Capable of understanding and complying with the protocol requirements and signed informed consent.
- Cohort B:
- Pathologically confirmed differentiated thyroid cancer (DTC) other than PTC, which includes follicular thyroid cancer (FTC), Hurthle cell carcinoma, and poorly-differentiated thyroid cancer.
- The patient is in advanced stage, which includes recurrent, metastatic, unresectable, or persistent disease.
- The patients are RAI-refractory* or ineligible for RAI therapy**.
- The definitions of RAI-refractory are one of the following criteria: no uptake of RAI in the tumor, uptake of RAI in some tumors but no uptake in other tumors, disease progression in spite of RAI uptake in the tumors, or accumulated RAI dose ≥ 600 mCi.
- the definitions of ineligible for RAI therapy are one of the following criteria: patients are unable to have RAI therapy due to some reasons, such as not received total thyroidectomy, unable to receive total thyroidectomy, or unable to have self-care in the isolation room.
- The patient needs systemic therapy.
- There are archived tumor samples available and the date of archived tumor sampling must be not more than 5 years from screening date. If there is no archived tumor sample available or the tumor sampling date is more than 5 years from screening date, re-biopsy is needed. If the quality of tumor sample is not fit for NGS oncopanel test, re-biopsy is needed.
- Age ≥ the legal age.
- Life expectancy greater than 6 months.
- Capable of understanding and complying with the protocol requirements and signed informed consent.
- Cohort C:
- Pathologically confirmed medullary thyroid carcinoma (MTC).
- The patient is in advanced stage, which includes recurrent, metastatic, unresectable, or persistent disease.
- There are archived tumor samples available and the date of archived tumor sampling must be not more than 5 years from screening date. If there is no archived tumor sample available or the tumor sampling date is more than 5 years from screening date, re-biopsy is needed. If the quality of tumor sample is not fit for NGS oncopanel test, re-biopsy is needed.
- Age ≥ the legal age.
- Life expectancy greater than 6 months.
- Capable of understanding and complying with the protocol requirements and signed informed consent.
- Cohort D:
- Pathologically confirmed anaplastic thyroid carcinoma (ATC).
- There are archived tumor samples available and the date of archived tumor sampling must be not more than 5 years from screening date. If there is no archived tumor sample available or the tumor sampling date is more than 5 years from screening date, re-biopsy is needed. If the quality of tumor sample is not fit for NGS oncopanel test, re-biopsy is needed.
- Age ≥ the legal age.
- Capable of understanding and complying with the protocol requirements and signed informed consent.
- Cohort E:
- The patients who had performed large NGS oncopanel test (ACTOnco) previously meet all the inclusion criteria of cohort A, B, C or D except the criteria of archived tumor sample requirement. These patients do not need to take archived tumor sample for NGS oncopanel test but need to take archived tumor sample for TERT promoter mutation and peripheral blood sampling.
- -
Who cannot join
- Cohort A:
- Inability and unwillingness to give informed consent.
- The patients have no evidence of disease before systemic treatment.
- The patients have stable residual disease or metastatic disease without progression and do not need systemic therapies.
- The patients do not intend to have systemic therapies.
- Patients do not agree to provide archived tumor samples and blood samples or they do not agree to do tumor biopsy when archived tumor samples are not available or inadequate for NGS oncopanel test.
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- The date of archived tumor sampling is more than 5 years from screening date.
- Patients refuse for collection of clinical data and follow-up.
- Mental status is not fit for further treatment or data collection.
- Cohort B:
- Inability and unwillingness to give informed consent.
- The patients have no evidence of disease before systemic treatment.
- The patients have stable residual disease or metastatic disease without progression and do not need systemic therapies.
- The patients do not intend to have systemic therapies.
- Patients do not agree to provide archived tumor samples and blood samples or they do not agree to do tumor biopsy when archived tumor samples are not available or inadequate for NGS oncopanel test.
- The date of archived tumor sampling is more than 5 years from screening date.
- Patients refuse for collection of clinical data and follow-up.
- Mental status is not fit for further treatment or data collection.
- Cohort C:
- Inability and unwillingness to give informed consent.
- The patients have no evidence of disease before systemic treatment.
- Patients do not agree to provide archived tumor samples and blood samples or they do not agree to do tumor biopsy when archived tumor samples are not available or inadequate for NGS oncopanel test.
- The date of archived tumor sampling is more than 5 years from screening date.
- Patients refuse for collection of clinical data and follow-p.
- Mental status is not fit for further treatment or data collection.
- Cohort D:
- Inability and unwillingness to give informed consent.
- Patients do not agree to provide archived tumor samples and blood samples or they do not agree to do tumor biopsy when archived tumor samples are not available or inadequate for NGS oncopanel test.
- The date of archived tumor sampling is more than 5 years from screening date.
- Patients refuse for collection of clinical data and follow up.
- Cohort E:
- The patients do not meet all exclusion criteria of cohort A, B, C, or D except for providing archived tumor sample.
- -
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Taiwan9 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Cancer Center
Taipei
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tri-service General Hospital
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan
About this study
Because one cancer type may harbor various genetic aberrations, it is not enough to check only one or a few genes for a patient to choose the adequate treatment. Because the advance in multiplex genomic testing, several NGS-based cancer-associated genetic panel tests (oncopanel) have been developed and used to identify the genetic alterations, particularly the actionable genes, in each patient. Large scale checks of oncopanel have been executed in US. The study showed the genetic alterations in various cancer types and 11% of the patients had further molecular targeted therapy based on the result of the oncopanel test. Similar program was also conducted in Japan. Moreover, the oncopanel tests have been implicated in their clinical practice and the cost was reimbursed by the government of Japan and Korea recently. Precision medicine and such personalized treatment is the trend of cancer treatment. The trend of such treatment patterns is also observed in Taiwan. The genetic background for cancer treatment may also be different among different areas and races. There is short of genetic alteration data in Taiwanese cancer patients. To understand the landscape of genetic aberrations of cancer in Taiwan, large scale survey of the cancer patients is indicated. investigators propose to evaluate the landscape of genetic aberrations in cancer patients via oncopaenl test and collect the clinical data of the patients. The result of the oncopanel test will be provided to patients and their attending physicians as reference for their further treatment. In addition, investigators want to correlate the clinical outcome with the genetic aberrations of the cancer patients in Taiwan. Thyroid cancers are divided into differentiated thyroid cancer (DTC), medullary and anaplastic carcinoma. The majority of the patients are DTC. Different from other cancer type, radioactive iodine (RAI) therapy is usually the main treatment for advanced DTC. Multitargeted kinase inhibitors are indicated for advanced DTC refractory to RAI therapy and advanced medullary thyroid cancer. For anaplastic thyroid cancer, the prognosis is poor in spite of chemotherapy or radiation therapy. BRAF or NTRK targeted therapies are suggested if the patients have these genetic aberrations. Thyroid cancer patients have various genetic aberrations, including BRAF, RAS, RET, NTRK and others. Various gene specific kinase inhibitors have been developed and demonstrated the efficacy for the treatment of advanced thyroid cancer in addition to current standard therapies. Thyroid cancer is a cancer type with high percentage of driver gene aberration, however the genetic landscape of thyroid cancer is not well understood in Taiwan. In the current study, investigators want to investigate the genetic aberrations of advanced thyroid cancers by performing the NGS oncopanel.
Read the detailed description
Cancer is the most common cause of death in Taiwan since 1982. The incidence of cancer is increasing worldwide, including Taiwan. Cancers in early stage can usually be treated by surgery with a good prognosis. However, the prognosis for recurrent, locally advanced or metastatic cancers is poor with a shorter survival. Systemic treatments are usually indicated for these patients. Chemotherapy is the mainstay for advanced cancer patients. However, the advances in the understanding of cancer biology and identification of targeted therapeutics not only increase the treatment strategies of cancer but also improve the survival and quality of life of the cancer patients. There are more and more molecularly targeted therapy developed and approved for the treatment of advanced cancer patients currently, which makes the beginning of precision cancer medicine. There are more and more treatments can be used based on the genetic aberrations of the cancers. Because one cancer type may harbor various genetic aberrations, it is not enough to check only one or a few genes for a patient to choose the adequate treatment. Because the advance in multiplex genomic testing, several NGS-based cancer-associated genetic panel tests (oncopanel) have been developed and used to identify the genetic alterations, particularly the actionable genes, in each patient. Large scale checks of oncopanel have been executed in US. The study showed the genetic alterations in various cancer types and 11% of the patients had further molecular targeted therapy based on the result of the oncopanel test. Similar program was also conducted in Japan. Moreover, the oncopanel tests have been implicated in their clinical practice and the cost was reimbursed by the government of Japan and Korea recently. Precision medicine and such personalized treatment is the trend of cancer treatment. The trend of such treatment patterns is also observed in Taiwan. The genetic background for cancer treatment may also be different among different areas and races. There is short of genetic alteration data in Taiwanese cancer patients. To understand the landscape of genetic aberrations of cancer in Taiwan, large scale survey of the cancer patients is indicated. investigators propose to evaluate the landscape of genetic aberrations in cancer patients via oncopaenl test and collect the clinical data of the patients. The result of the oncopanel test will be provided to patients and their attending physicians as reference for their further treatment. In addition, investigators want to correlate the clinical outcome with the genetic aberrations of the cancer patients in Taiwan. Thyroid cancers are divided into differentiated thyroid cancer (DTC), medullary and anaplastic carcinoma. The majority of the patients are DTC. Different from other cancer type, radioactive iodine (RAI) therapy is usually the main treatment for advanced DTC. Multitargeted kinase inhibitors are indicated for advanced DTC refractory to RAI therapy and advanced medullary thyroid cancer. For anaplastic thyroid cancer, the prognosis is poor in spite of chemotherapy or radiation therapy. BRAF or NTRK targeted therapies are suggested if the patients have these genetic aberrations. Thyroid cancer patients have various genetic aberrations, including BRAF, RAS, RET, NTRK and others. Various gene specific kinase inhibitors have been developed and demonstrated the efficacy for the treatment of advanced thyroid cancer in addition to current standard therapies. Thyroid cancer is a cancer type with high percentage of driver gene aberration, however the genetic landscape of thyroid cancer is not well understood in Taiwan. In the current study, investigators want to investigate the genetic aberrations of advanced thyroid cancers by performing the NGS oncopanel. Then investigators can understand the genetic aberrations of these patients in Taiwan and help search potential treatment targets for these patients.
- Conditions
- Thyroid Cancer
- Being tested
- A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients
- Keywords
- advanced thyroid cancers, Registry Study
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer PatientsOther
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | patients who were pathologically (histologically) diagnosed as papillary carcinoma (PTC). They are in advanced stage and need systemic therapies. These patients may be unresectable, recurrent, persistent, or metastatic disease with RAI refractory or ineligible and need systemic therapies. Receives: Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients | |
| Cohort B | patients who were pathologically diagnosed as DTC other than PTC, which includes follicular carcinoma, Hurthle cell carcinoma, and poorly differentiated carcinoma. The patients are in advanced stage and need systemic therapies. These patients may be unresectable, recurrent, persistent, or metastatic disease with RAI refractory or ineligible and need systemic therapies. Receives: Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients | |
| Cohort C | patients who were pathologically diagnosed as medullary thyroid cancer (MTC) with persistent disease. Receives: Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients | |
| Cohort D | patients who were pathologically diagnosed as anaplastic thyroid cancer (ATC). Receives: Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients | |
| Cohort E | the patients who had performed large scale NGS oncopanel test previously and fulfil with the criteria in cohort A, B, C, or D.
The patients must meet all the inclusion criteria and none of the exclusion criteria in each cohort. Receives: Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the genetic profiles in advanced thyroid cancer patients in Taiwan.
ACTonco+ACTFusion
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start29 Aug 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541380
- Sponsor's protocol ID
- T2322
- Status last verified
- Apr 2025
- First submitted
- 4 Sep 2022
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients (TOPICS-THYROID)
- ClinicalTrials.gov ID
- NCT05541380
- Acronym / sponsor ID
- T2322
- Conditions
- Thyroid Cancer
- Keywords
- advanced thyroid cancers, Registry Study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Sep 2022 (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.
Because one cancer type may harbor various genetic aberrations, it is not enough to check only one or a few genes for a patient to choose the adequate treatment. Because the advance in multiplex genomic testing, several NGS-based cancer-associated genetic panel tests (oncopanel) have been developed and used to identify the genetic alterations, particularly the actionable genes, in each patient. Large scale checks of oncopanel have been executed in US. The study showed the genetic alterations in various cancer types and 11% of the patients had further molecular targeted therapy based on the result of the oncopanel test. Similar program was also conducted in Japan. Moreover, the oncopanel tests have been implicated in their clinical practice and the cost was reimbursed by the government of Japan and Korea recently. Precision medicine and such personalized treatment is the trend of cancer treatment. The trend of such treatment patterns is also observed in Taiwan. The genetic background for cancer treatment may also be different among different areas and races. There is short of genetic alteration data in Taiwanese cancer patients. To understand the landscape of genetic aberrations of cancer in Taiwan, large scale survey of the cancer patients is indicated. investigators propose to evaluate the landscape of genetic aberrations in cancer patients via oncopaenl test and collect the clinical data of the patients. The result of the oncopanel test will be provided to patients and their attending physicians as reference for their further treatment. In addition, investigators want to correlate the clinical outcome with the genetic aberrations of the cancer patients in Taiwan. Thyroid cancers are divided into differentiated thyroid cancer (DTC), medullary and anaplastic carcinoma. The majority of the patients are DTC. Different from other cancer type, radioactive iodine (RAI) therapy is usually the main treatment for advanced DTC. Multitargeted kinase inhibitors are indicated for advanced DTC refractory to RAI therapy and advanced medullary thyroid cancer. For anaplastic thyroid cancer, the prognosis is poor in spite of chemotherapy or radiation therapy. BRAF or NTRK targeted therapies are suggested if the patients have these genetic aberrations. Thyroid cancer patients have various genetic aberrations, including BRAF, RAS, RET, NTRK and others. Various gene specific kinase inhibitors have been developed and demonstrated the efficacy for the treatment of advanced thyroid cancer in addition to current standard therapies. Thyroid cancer is a cancer type with high percentage of driver gene aberration, however the genetic landscape of thyroid cancer is not well understood in Taiwan. In the current study, investigators want to investigate the genetic aberrations of advanced thyroid cancers by performing the NGS oncopanel.
Detailed description
Cancer is the most common cause of death in Taiwan since 1982. The incidence of cancer is increasing worldwide, including Taiwan. Cancers in early stage can usually be treated by surgery with a good prognosis. However, the prognosis for recurrent, locally advanced or metastatic cancers is poor with a shorter survival. Systemic treatments are usually indicated for these patients. Chemotherapy is the mainstay for advanced cancer patients. However, the advances in the understanding of cancer biology and identification of targeted therapeutics not only increase the treatment strategies of cancer but also improve the survival and quality of life of the cancer patients. There are more and more molecularly targeted therapy developed and approved for the treatment of advanced cancer patients currently, which makes the beginning of precision cancer medicine. There are more and more treatments can be used based on the genetic aberrations of the cancers. Because one cancer type may harbor various genetic aberrations, it is not enough to check only one or a few genes for a patient to choose the adequate treatment. Because the advance in multiplex genomic testing, several NGS-based cancer-associated genetic panel tests (oncopanel) have been developed and used to identify the genetic alterations, particularly the actionable genes, in each patient. Large scale checks of oncopanel have been executed in US. The study showed the genetic alterations in various cancer types and 11% of the patients had further molecular targeted therapy based on the result of the oncopanel test. Similar program was also conducted in Japan. Moreover, the oncopanel tests have been implicated in their clinical practice and the cost was reimbursed by the government of Japan and Korea recently. Precision medicine and such personalized treatment is the trend of cancer treatment. The trend of such treatment patterns is also observed in Taiwan. The genetic background for cancer treatment may also be different among different areas and races. There is short of genetic alteration data in Taiwanese cancer patients. To understand the landscape of genetic aberrations of cancer in Taiwan, large scale survey of the cancer patients is indicated. investigators propose to evaluate the landscape of genetic aberrations in cancer patients via oncopaenl test and collect the clinical data of the patients. The result of the oncopanel test will be provided to patients and their attending physicians as reference for their further treatment. In addition, investigators want to correlate the clinical outcome with the genetic aberrations of the cancer patients in Taiwan. Thyroid cancers are divided into differentiated thyroid cancer (DTC), medullary and anaplastic carcinoma. The majority of the patients are DTC. Different from other cancer type, radioactive iodine (RAI) therapy is usually the main treatment for advanced DTC. Multitargeted kinase inhibitors are indicated for advanced DTC refractory to RAI therapy and advanced medullary thyroid cancer. For anaplastic thyroid cancer, the prognosis is poor in spite of chemotherapy or radiation therapy. BRAF or NTRK targeted therapies are suggested if the patients have these genetic aberrations. Thyroid cancer patients have various genetic aberrations, including BRAF, RAS, RET, NTRK and others. Various gene specific kinase inhibitors have been developed and demonstrated the efficacy for the treatment of advanced thyroid cancer in addition to current standard therapies. Thyroid cancer is a cancer type with high percentage of driver gene aberration, however the genetic landscape of thyroid cancer is not well understood in Taiwan. In the current study, investigators want to investigate the genetic aberrations of advanced thyroid cancers by performing the NGS oncopanel. Then investigators can understand the genetic aberrations of these patients in Taiwan and help search potential treatment targets for these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patientspatients who were pathologically (histologically) diagnosed as papillary carcinoma (PTC). They are in advanced stage and need systemic therapies. These patients may be unresectable, recurrent, persistent, or metastatic disease with RAI refractory or ineligible and need systemic therapies. |
| Cohort B | – | Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patientspatients who were pathologically diagnosed as DTC other than PTC, which includes follicular carcinoma, Hurthle cell carcinoma, and poorly differentiated carcinoma. The patients are in advanced stage and need systemic therapies. These patients may be unresectable, recurrent, persistent, or metastatic disease with RAI refractory or ineligible and need systemic therapies. |
| Cohort C | – | Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patientspatients who were pathologically diagnosed as medullary thyroid cancer (MTC) with persistent disease. |
| Cohort D | – | Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patientspatients who were pathologically diagnosed as anaplastic thyroid cancer (ATC). |
| Cohort E | – | Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patientsthe patients who had performed large scale NGS oncopanel test previously and fulfil with the criteria in cohort A, B, C, or D. The patients must meet all the inclusion criteria and none of the exclusion criteria in each cohort. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to include 250 advanced thyroid cancer patients, including 150 papillary thyroid cancer cancers (cohort A), and 50 non-PTC DTC, including follicular thyroid cancers, Hurthle cell carcinoma and poorly-differentiated carcinoma (cohort B), 25 medullary thyroid cancer (cohort C), and 25 anaplastic thyroid cancer (cohort D) in this study. There is no case number limitation for cohort E. However, we estimate to enroll approximately 50 patients in cohort E. In cohort A, the enrolled number of men and women must be ≥ 50 for each group.
Key inclusion criteria (37 listed)
- Pathologically confirmed papillary thyroid carcinoma (PTC).
- The patient is in advanced stage, which includes recurrent, metastatic, unresectable, or persistent disease.
- The patients are RAI-refractory* or ineligible for RAI therapy**.
- The definitions of RAI-refractory are one of the following criteria: no uptake of RAI in the tumor, uptake of RAI in some tumors but no uptake in other tumors, disease progression in spite of RAI uptake in the tumors, or accumulated RAI dose ≥ 600 mCi.
- the definitions of ineligible for RAI therapy are one of the following criteria: patients are unable to have RAI therapy due to some reasons, such as not received total thyroidectomy, unable to receive total thyroidectomy, or unable to have self-care in the isolation room.
Key exclusion criteria (33 listed)
- Inability and unwillingness to give informed consent.
- The patients have no evidence of disease before systemic treatment.
- The patients have stable residual disease or metastatic disease without progression and do not need systemic therapies.
- The patients do not intend to have systemic therapies.
- Patients do not agree to provide archived tumor samples and blood samples or they do not agree to do tumor biopsy when archived tumor samples are not available or inadequate for NGS oncopanel test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer PatientsA Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients | Other | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E |
Primary outcome
To evaluate the genetic profiles in advanced thyroid cancer patients in Taiwan.
Time frame: 5 years
ACTonco+ACTFusion
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 20 Apr 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer, 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 37 inclusion and 33 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the genetic profiles in advanced thyroid cancer patients in Taiwan. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2025.