Oncogenetic Panel and Integrated Clinical Data Registry Study for Wild Type Gastrointestinal Stromal Tumor Patients

NCT04821895 · tracked via the Priya Life Science Taiwan tracker

Sponsor

National Health Research Institutes, Taiwan

Phase

Observational

Started

2021-08-28

Last updated

2026-07-02

Condition(s) studied

Gastrointestinal Stromal Tumor (GIST)

Study 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.

Eligibility

Sex

ALL

Min age

20 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Pathologically confirmed GIST. 2. 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) 3. The tumors were tested for wild type c-KIT and PDGFRA. 4. 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. 5. The patients who are systemic treatment naïve or have received prior systemic treatment are all eligible. 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. Exclusion Criteria: * Patients will be excluded from the study if they meet any of the following criteria: 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. 3. Patients refused for collection of clinical data and follow up. 4. Mental status is not fit for further treatment or data collection.

Primary outcome measure(s)

genetic profiles in gastrointestinal stromal tumor (GIST) patients — 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.

Trial sites (11)

Facility	City	Region
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	Taiwan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04821895 on ClinicalTrials.gov ↗ ← All trials in Taiwan