Gastrointestinal Stromal Tumor (GIST)GISTNCT04821895
Oncogenetic Panel and Integrated Clinical Data Registry Study for Wild Type Gastrointestinal Stromal Tumor Patients
An observational study of Gastrointestinal Stromal Tumor (GIST), run by National Health Research Institutes, Taiwan at 11 sites in Taiwan.
Trial summary
The genetic background for cancer treatment may also be different among different areas and races. There is lack of Taiwanese data of genetic alterations in cancer patients. To understand the landscape of genetic aberrations of cancer in Taiwan, large scale survey of the cancer patients is indicated. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumor (GIST)
- How many people
- 50 participants
- Where
- 11 sitesTaiwan
- Study dates
- 28 Aug 2021to 31 Dec 2029
- How long will I take part?
- 9 Years
- 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: Wild Type Gastrointestinal stromal tumor (GIST)
Who may be able to join
- Pathologically confirmed GIST.
- The tumors can be resected, unresectable, recurrent or metastatic and the patients had ever received, are receiving or will receive systemic treatment (adjuvant, neoadjuvant or salvage TKI or other targeted agents)
- The tumors were tested for wild type c-KIT and PDGFRA.
- There are archived tumor samples available or the patients agree to do tumor biopsy for oncopanel test if there is no tumor sample or not enough tumor sample available.
- The patients who are systemic treatment naïve or have received prior systemic treatment are all eligible.
- Age - the legal age.
- Life expectancy greater than 6 months
- Capable of understanding and complying with the protocol requirements and signed informed consent.
Who cannot join
- Patients will be excluded from the study if they meet any of the following criteria:
- 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.
- Patients refused for collection of clinical data and follow up.
- Mental status is not fit for further treatment or data collection.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Taiwan11 sites
Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Mackay Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
Chang Gung Memorial Hospital
Taoyuan
About this study
Official title: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registration Study for Wild Type Gastrointestinal Stromal Tumor Patients (TOPICS-GIST)
The genetic background for cancer treatment may also be different among different areas and races. There is lack of Taiwanese data of genetic alterations in cancer patients. To understand the landscape of genetic aberrations of cancer in Taiwan, large scale survey of the cancer patients is indicated. In this pilot study, the investigators want 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 returned to patient and their attending physician for reference of their further treatment. In addition, the investigators want to correlate the clinical outcome with the genetic aberrations of the cancer patients in Taiwan. Gastrointestinal stromal tumor (GIST) is a rare cancer compared with the other solid tumors. C-KIT or PDGFRA mutation is found in approximately 85-90% of GISTs. Imatinib, a tyrosine kinase inhibitor targeting c-KIT, has been used to treat advanced GIST successfully since 2000. However, resistance to imatinib may develop either via secondary mutation of c-KIT or primary resistance to those with wild type c-KIT and PDGFRA. Although sunitinib and regorafenib have been approved as second and third line of treatment for advanced GIST, the progression free survival were only 6.8 and 4.8 months, respectively. The genetic landscape of GIST with wild type c-KIT and PDGFRA was less studied. In the current study, the investigators want to focus on the GISTs with wild type c-KIT and PDGFRA to perform the NGS oncopanel for these patients. Then the investigators can understand the genetic aberrations of these patients (wild type GIST) and help for searching the potential treatment targets to them.
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 treated with surgery with a good prognosis. However, the prognosis for recurrent, locally advanced or metastatic cancers are poor with a shorter survival. Systemic treatments are usually indicated for these patients. Chemotherapy is the main stay 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 improves 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 habor 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 test, several NGS-based cancer-associated genetic panel test (oncopanel) have been developed and used to identify the genetic alterations in each patient, particularly the actionable genes. 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. The similar program was done in Japan. Moreover, the oncopanel test have been implicated in their clinical practice and the cost was reimbursed by the government in Japan and Korea recently. The precision medicine and such personalized treatment is the trend for 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 lack of Taiwanese data of genetic alterations in cancer patients. To understand the landscape of genetic aberrations of cancer in Taiwan, large scale survey of the cancer patients is indicated. In this pilot study, the investigators want 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 returned to patient and their attending physician for reference of their further treatment. In addition, the investigators want to correlate the clinical outcome with the genetic aberrations of the cancer patients in Taiwan. Gastrointestinal stromal tumor (GIST) is a rare cancer compared with the other solid tumors. C-KIT or PDGFRA mutation is found in approximately 85-90% of GISTs. Imatinib, a tyrosine kinase inhibitor targeting c-KIT, has been used to treat advanced GIST successfully since 2000. However, resistance to imatinib may develop either via secondary mutation of c-KIT or primary resistance to those with wild type c-KIT and PDGFRA. Although sunitinib and regorafenib have been approved as second and third line of treatment for advanced GIST, the progression free survival were only 6.8 and 4.8 months, respectively. The genetic landscape of GIST with wild type c-KIT and PDGFRA was less studied. In the current study, wthe investigators want to focus on the GISTs with wild type c-KIT and PDGFRA to perform the NGS oncopanel for these patients. Then the investigators can understand the genetic aberrations of these patients (wild type GIST) and help for searching the potential treatment targets to the participants.
- Conditions
- Gastrointestinal Stromal Tumor (GIST)
- Keywords
- Gastrointestinal Stromal Tumor(GIST), Oncogenetic Panel
- Medical subject headings
- Gastrointestinal Stromal Tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic profiles in gastrointestinal stromal tumor (GIST) patients
To evaluate the genetic profiles in gastrointestinal stromal tumor (GIST) patients without c-KIT and PDGFRA mutation (wild type) in Taiwan.
Measured: 5-year time frame
Secondary outcomes (3)
Collect clinical data of wild type GIST patients
Collect clinical data of wild type GIST patients
Measured: 5-year time frame
To correlate the clinical characteristics, treatment and outcome of wild type GIST patients with the genetic profile in Taiwan.
To correlate the clinical characteristics, treatment and outcome of wild type GIST patients
Measured: 5-year time frame
To help for search the potential targeted agents for the treatment of these wild type GIST patients
To help for search the potential targeted agents for the treatment of these wild type GIST patients
Measured: 5-year time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start28 Aug 2021
- Primary completionDec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal Tumor (GIST)Studies 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 9 Years
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital (TSGH), Mackay Memorial Hospital, Chang Gung Memorial Hospital, China Medical University Hospital, Taichung Veterans General Hospital, Changhua Christian Hospital, Kaohsiung Veterans General Hospital., National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Taoyuan General Hospital
- Responsible party
- Sponsor
- Investigators
- Hui-Jen Tsai, M.D., Principal investigator, National Health Research Institutes, TaiwanLi-Tzong Chen, Ph.D, Study chair, leochen@nhri.org.tw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821895
- Sponsor's protocol ID
- T1221
- Acronym
- GIST
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2021
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registration Study for Wild Type Gastrointestinal Stromal Tumor Patients (TOPICS-GIST)
- ClinicalTrials.gov ID
- NCT04821895
- Acronym / sponsor ID
- GIST / T1221
- Conditions
- Gastrointestinal Stromal Tumor (GIST)
- Keywords
- Gastrointestinal Stromal Tumor(GIST), Oncogenetic Panel
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital (TSGH), Mackay Memorial Hospital, Chang Gung Memorial Hospital, China Medical University Hospital, Taichung Veterans General Hospital, Changhua Christian Hospital, Kaohsiung Veterans General Hospital., National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Taoyuan General Hospital
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Mar 2021 (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.
The genetic background for cancer treatment may also be different among different areas and races. There is lack of Taiwanese data of genetic alterations in cancer patients. To understand the landscape of genetic aberrations of cancer in Taiwan, large scale survey of the cancer patients is indicated. In this pilot study, the investigators want 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 returned to patient and their attending physician for reference of their further treatment. In addition, the investigators want to correlate the clinical outcome with the genetic aberrations of the cancer patients in Taiwan. Gastrointestinal stromal tumor (GIST) is a rare cancer compared with the other solid tumors. C-KIT or PDGFRA mutation is found in approximately 85-90% of GISTs. Imatinib, a tyrosine kinase inhibitor targeting c-KIT, has been used to treat advanced GIST successfully since 2000. However, resistance to imatinib may develop either via secondary mutation of c-KIT or primary resistance to those with wild type c-KIT and PDGFRA. Although sunitinib and regorafenib have been approved as second and third line of treatment for advanced GIST, the progression free survival were only 6.8 and 4.8 months, respectively. The genetic landscape of GIST with wild type c-KIT and PDGFRA was less studied. In the current study, the investigators want to focus on the GISTs with wild type c-KIT and PDGFRA to perform the NGS oncopanel for these patients. Then the investigators can understand the genetic aberrations of these patients (wild type GIST) and help for searching the potential treatment targets to them.
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 treated with surgery with a good prognosis. However, the prognosis for recurrent, locally advanced or metastatic cancers are poor with a shorter survival. Systemic treatments are usually indicated for these patients. Chemotherapy is the main stay 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 improves 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 habor 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 test, several NGS-based cancer-associated genetic panel test (oncopanel) have been developed and used to identify the genetic alterations in each patient, particularly the actionable genes. 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. The similar program was done in Japan. Moreover, the oncopanel test have been implicated in their clinical practice and the cost was reimbursed by the government in Japan and Korea recently. The precision medicine and such personalized treatment is the trend for 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 lack of Taiwanese data of genetic alterations in cancer patients. To understand the landscape of genetic aberrations of cancer in Taiwan, large scale survey of the cancer patients is indicated. In this pilot study, the investigators want 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 returned to patient and their attending physician for reference of their further treatment. In addition, the investigators want to correlate the clinical outcome with the genetic aberrations of the cancer patients in Taiwan. Gastrointestinal stromal tumor (GIST) is a rare cancer compared with the other solid tumors. C-KIT or PDGFRA mutation is found in approximately 85-90% of GISTs. Imatinib, a tyrosine kinase inhibitor targeting c-KIT, has been used to treat advanced GIST successfully since 2000. However, resistance to imatinib may develop either via secondary mutation of c-KIT or primary resistance to those with wild type c-KIT and PDGFRA. Although sunitinib and regorafenib have been approved as second and third line of treatment for advanced GIST, the progression free survival were only 6.8 and 4.8 months, respectively. The genetic landscape of GIST with wild type c-KIT and PDGFRA was less studied. In the current study, wthe investigators want to focus on the GISTs with wild type c-KIT and PDGFRA to perform the NGS oncopanel for these patients. Then the investigators can understand the genetic aberrations of these patients (wild type GIST) and help for searching the potential treatment targets to the participants.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 9 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Wild Type Gastrointestinal stromal tumor (GIST)
Key inclusion criteria (8 listed)
- Pathologically confirmed GIST.
- The tumors can be resected, unresectable, recurrent or metastatic and the patients had ever received, are receiving or will receive systemic treatment (adjuvant, neoadjuvant or salvage TKI or other targeted agents)
- The tumors were tested for wild type c-KIT and PDGFRA.
- There are archived tumor samples available or the patients agree to do tumor biopsy for oncopanel test if there is no tumor sample or not enough tumor sample available.
- The patients who are systemic treatment naïve or have received prior systemic treatment are all eligible.
Key exclusion criteria (5 listed)
- Patients will be excluded from the study if they meet any of the following criteria:
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
genetic profiles in gastrointestinal stromal tumor (GIST) patients
Time frame: 5-year time frame
To evaluate the genetic profiles in gastrointestinal stromal tumor (GIST) patients without c-KIT and PDGFRA mutation (wild type) in Taiwan.
3 secondary outcomes
Collect clinical data of wild type GIST patients
Time frame: 5-year time frame
To correlate the clinical characteristics, treatment and outcome of wild type GIST patients with the genetic profile in Taiwan.
Time frame: 5-year time frame
To help for search the potential targeted agents for the treatment of these wild type GIST patients
Time frame: 5-year time frame
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 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
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GIST
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.
Hui-Jen Tsai, M.D. principal investigator
National Health Research Institutes, Taiwan
Li-Tzong Chen, Ph.D study chair
leochen@nhri.org.tw
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Stromal Tumor (GIST), run by National Health Research Institutes, Taiwan at 11 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 8 inclusion and 5 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 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
genetic profiles in gastrointestinal stromal tumor (GIST) patients (time frame: 5-year time frame). 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 2 Jul 2026.