Oncogenetic Panel and Integrated Clinical Data Registry Study for Wild Type Gastrointestinal Stromal Tumor Patients
GIST
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registration Study for Wild Type Gastrointestinal Stromal Tumor Patients (TOPICS-GIST)
1 other identifier
observational
50
1 country
11
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2021
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 30, 2021
CompletedStudy Start
First participant enrolled
August 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
January 20, 2026
January 1, 2026
8.3 years
March 25, 2021
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
5-year time frame
Secondary Outcomes (3)
Collect clinical data of wild type GIST patients
5-year time frame
To correlate the clinical characteristics, treatment and outcome of wild type GIST patients with the genetic profile in Taiwan.
5-year time frame
To help for search the potential targeted agents for the treatment of these wild type GIST patients
5-year time frame
Eligibility Criteria
Wild Type Gastrointestinal stromal tumor (GIST)
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Health Research Institutes, Taiwanlead
- National Taiwan University Hospitalcollaborator
- Taipei Veterans General Hospital, Taiwancollaborator
- Tri-Service General Hospitalcollaborator
- Mackay Memorial Hospitalcollaborator
- Chang Gung Memorial Hospitalcollaborator
- China Medical University Hospitalcollaborator
- Taichung Veterans General Hospitalcollaborator
- Changhua Christian Hospitalcollaborator
- Kaohsiung Veterans General Hospital.collaborator
- National Cheng-Kung University Hospitalcollaborator
- Kaohsiung Medical University Chung-Ho Memorial Hospitalcollaborator
- Taoyuan General Hospitalcollaborator
Study Sites (11)
Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital
Taoyuan District, Taiwan
Biospecimen
oncopaenl test
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hui-Jen Tsai, M.D.
National Health Research Institutes, Taiwan
- STUDY CHAIR
Li-Tzong Chen, Ph.D
leochen@nhri.org.tw
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 9 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2021
First Posted
March 30, 2021
Study Start
August 28, 2021
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
January 20, 2026
Record last verified: 2026-01