Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04821895 |
| Other study ID # |
T1221 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 28, 2021 |
| Est. completion date |
December 31, 2029 |
Study information
| Verified date |
November 2023 |
| Source |
National Health Research Institutes, Taiwan |
| Contact |
Hui-Jen Tsai, M.D. |
| Phone |
886-6-2083422 |
| Email |
hjtsai[@]nhri.org.tw |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
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.
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.
