Trial Title:
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients (TOPICS-THYROID)
NCT ID:
NCT05541380
Condition:
Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Conditions: Keywords:
advanced thyroid cancers
Registry Study
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients
Description:
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced
Thyroid Cancer Patients
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C
Arm group label:
Cohort D
Arm group label:
Cohort E
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
Cohort A:
1. Pathologically confirmed papillary thyroid carcinoma (PTC).
2. The patient is in advanced stage, which includes recurrent, metastatic,
unresectable, or persistent disease.
3. 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.
4. The patient needs systemic therapy.
5. 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.
6. Age ≥ the legal age.
7. Life expectancy greater than 6 months.
8. Capable of understanding and complying with the protocol requirements and signed
informed consent.
Cohort B:
1. Pathologically confirmed differentiated thyroid cancer (DTC) other than PTC, which
includes follicular thyroid cancer (FTC), Hurthle cell carcinoma, and
poorly-differentiated thyroid cancer.
2. The patient is in advanced stage, which includes recurrent, metastatic,
unresectable, or persistent disease.
3. 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.
4. The patient needs systemic therapy.
5. 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.
6. Age ≥ the legal age.
7. Life expectancy greater than 6 months.
8. Capable of understanding and complying with the protocol requirements and signed
informed consent.
Cohort C:
1. Pathologically confirmed medullary thyroid carcinoma (MTC).
2. The patient is in advanced stage, which includes recurrent, metastatic,
unresectable, or persistent disease.
3. 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.
4. Age ≥ the legal age.
5. Life expectancy greater than 6 months.
6. Capable of understanding and complying with the protocol requirements and signed
informed consent.
Cohort D:
1. Pathologically confirmed anaplastic thyroid carcinoma (ATC).
2. 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.
3. Age ≥ the legal age.
4. 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:
1. Inability and unwillingness to give informed consent.
2. The patients have no evidence of disease before systemic treatment.
3. The patients have stable residual disease or metastatic disease without progression
and do not need systemic therapies.
4. The patients do not intend to have systemic therapies.
5. 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.
6. The date of archived tumor sampling is more than 5 years from screening date.
7. Patients refuse for collection of clinical data and follow-up.
8. Mental status is not fit for further treatment or data collection.
Cohort B:
1. Inability and unwillingness to give informed consent.
2. The patients have no evidence of disease before systemic treatment.
3. The patients have stable residual disease or metastatic disease without progression
and do not need systemic therapies.
4. The patients do not intend to have systemic therapies.
5. 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.
6. The date of archived tumor sampling is more than 5 years from screening date.
7. Patients refuse for collection of clinical data and follow-up.
8. Mental status is not fit for further treatment or data collection.
Cohort C:
1. Inability and unwillingness to give informed consent.
2. The patients have no evidence of disease before systemic treatment.
3. 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.
4. The date of archived tumor sampling is more than 5 years from screening date.
5. Patients refuse for collection of clinical data and follow-p.
6. Mental status is not fit for further treatment or data collection.
Cohort D:
1. Inability and unwillingness to give informed consent.
2. 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.
3. The date of archived tumor sampling is more than 5 years from screening date.
4. 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.
-
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Mei-Yueh Lee
Facility:
Name:
Kaohsiung Veterans General Hospital
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Hueng-Yuan Shen
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Chen-Yuan Lin
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chung-Jye Hung
Investigator:
Last name:
Chung-Jye Hung
Email:
Principal Investigator
Facility:
Name:
National Taiwan University Cancer Center
Address:
City:
Taipei
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Chia-Chi Lin
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Chia-Chi Lin
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Jui-Yu Chen
Facility:
Name:
Tri-service General Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Ren-Hua Yehn
Facility:
Name:
Linkou Chang Gung Memorial Hospital
Address:
City:
Taoyuan
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Miaw-Jene Liou
Start date:
August 29, 2022
Completion date:
December 31, 2030
Lead sponsor:
Agency:
National Health Research Institutes, Taiwan
Agency class:
Other
Source:
National Health Research Institutes, Taiwan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05541380
