Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04821895
Study type Observational [Patient Registry]
Source National Health Research Institutes, Taiwan
Contact Hui-Jen Tsai, M.D.
Phone 886-6-2083422
Email hjtsai@nhri.org.tw
Status Recruiting
Phase
Start date August 28, 2021
Completion date December 31, 2029

See also
  Status Clinical Trial Phase
Completed NCT02574663 - TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors Phase 1
Active, not recruiting NCT01991379 - MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST) Phase 1/Phase 2
Completed NCT01135849 - B-Receptor Signaling in Cardiomyopathy N/A
Completed NCT00623831 - A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen Phase 1
Completed NCT00464620 - Trial of Dasatinib in Advanced Sarcomas Phase 2
Completed NCT01294202 - A Study to Investigate the Safety and Efficacy of AT13387, Alone or in Combination With Imatinib, in Patients With GIST Phase 2
Completed NCT00785785 - A Study of Nilotinib Versus Imatinib in GIST Patients Phase 3
Recruiting NCT02443948 - Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST) N/A
Recruiting NCT01034670 - Advanced Gastrointestinal Endoscopic Imaging N/A
Completed NCT00867113 - Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST) Phase 2
Active, not recruiting NCT01391611 - Pazopanib in Imatinib Refractory or Intolerant Gastrointestinal Stromal Tumors (GIST) Phase 2
Terminated NCT02452424 - A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors Phase 1/Phase 2
Recruiting NCT03594422 - A Study of HQP1351 in Patients With GIST or Other Solid Tumors Phase 1
Recruiting NCT05453292 - Endoscopic Ultrasound Radiofrequency Ablation for GISTs N/A
Completed NCT00780494 - Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma Phase 2
Recruiting NCT04557969 - Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
Completed NCT03404076 - Unifying Advanced Treatment With Advanced Imaging
Completed NCT01316263 - A Study of IMC-3G3 in Previously Treated Patients With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors Phase 2
Terminated NCT00767234 - Permission to Collect Blood Over Time for Research N/A
Recruiting NCT01048281 - Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma