A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients (TOPICS-THYROID)
1 other identifier
observational
300
1 country
9
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 29, 2022
CompletedFirst Submitted
Initial submission to the registry
September 4, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
April 20, 2025
April 1, 2025
8.3 years
September 4, 2022
April 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the genetic profiles in advanced thyroid cancer patients in Taiwan.
ACTonco+ACTFusion
5 years
Study Arms (5)
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.
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.
Cohort C
patients who were pathologically diagnosed as medullary thyroid cancer (MTC) with persistent disease.
Cohort D
patients who were pathologically diagnosed as anaplastic thyroid cancer (ATC).
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.
Interventions
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients
Eligibility Criteria
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.
You may qualify if:
- 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.
- 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\*\*.
- +20 more criteria
You may not qualify if:
- 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.
- 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.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Cancer Center
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-service General Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan
Biospecimen
1. One H\&E staining slide, and 10-18 tissue slides (5 um thickness) for cancer panel. 2. Details of Tests/Collaborative Test Unit: Testing will take place in a certified precision medicine laboratory. 3. Non-tumor Sample (Blood): Eight (8) ml of blood in EDTA tube will be collected from the participant
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2022
First Posted
September 15, 2022
Study Start
August 29, 2022
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
April 20, 2025
Record last verified: 2025-04