A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients (TOPICS-THYROID)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2030
  • participants needed
    300
  • sponsor
    National Health Research Institutes, Taiwan
Updated on 13 October 2022
carcinoma
RET
cancer treatment
NTRK

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.

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.

Details
Condition Thyroid Cancer
Treatment A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients
Clinical Study IdentifierNCT05541380
SponsorNational Health Research Institutes, Taiwan
Last Modified on13 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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_
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

Exclusion Criteria

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note