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This is a prospective observational research to explore the frequency of Human leukocyte antigen A allele 02:01 (HLA*02:01) and the expression status of New York esophageal squamous cell carcinoma-1 (NY-ESO-1) in cancer patients in Taiwanese population.
T cell receptor (TCR)-engineered T cells with high affinity to NY-ESO-1 epitope presented by HLA-A*02:01 are potential therapeutic strategy against solid tumor, which show exciting results in several clinical studies. However, the prevalence of patients expressing HLA-A*02:01 and NY-ESO-1 in Taiwanese population is still unknown. This research aims to explore the prevalence of cancer patients expressing HLA-A*02:01 and NY-ESO-1 in Taiwanese population. Eligible patients with triple-negative breast cancer, hepatocellular carcinoma, head and neck squamous cell carcinoma excluding nasopharyngeal carcinoma, Lung squamous cell cancer, synovial sarcoma, esophageal squamous cell carcinoma, cervical cancer, or ovarian cancer will be enrolled. High resolution genotyping for HLA-A*02:01 and NY-ESO-1 expression status using IHC will be assessed in all enrolled patients. The frequency of HLA-A*02:01 allele and the prevalence of NY-ESO-1 positive expression will be analysed by pooled patient population and by specific tumor type.
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| Measure | Description | Time Frame |
|---|---|---|
| The frequency of HLA-A*02:01 allele in patients with confirmed diagnosed solid tumor. | To explore the frequency of HLA-A*02:01 allele using genotyping with high resolution in all eligible patients with confirmed diagnosed solid tumor. | 1 day |
| The prevalence of NY-ESO-1 positive expression in all tumor patients with HLA-A*02:01 allele. | To explore the prevalence of NY-ESO-1 positive expression using immunohistochemistry (IHC) in all patients with HLA-A*02:01 allele. | 1 day |
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Inclusion Criteria:
Able to understand and voluntarily sign an informed consent form (ICF).
Adult aged ≥ 18 years at the time of informed consent (or other age required by local regulations).
Confirmed diagnosis of any of the following solid tumor:
Patient who received standard curative or palliative therapy including but not limited to any targeted therapy based on mutation status for their cancer, or patient with advanced solid tumors for which there is no accepted therapy, standard therapies are no longer effective, or the patient refuses additional standard therapy.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
Body weight ≥ 50 Kg.
Life expectancy of ≥ 6 months.
Patient who agrees to provide the tumor sample for NY-ESO-1 IHC staining, from either fresh or archival tissue
Exclusion Criteria:
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Adult patients with confirmed diagnosis of any of the following solid tumor:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsi-Chi Chang | Contact | +886-2-2655-7688 | angela_chang@pharmaessentia.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital, Chiayi Branch | Recruiting | Chiayi City | Taiwan | Taiwan | ||
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| Taichung Veterans General Hospital |
| Recruiting |
| Taichung |
| Taiwan |
| 407219 |
| Taiwan |
| National Cheng Kung University Hospital | Recruiting | Tainan | Taiwan | 704 | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | Taiwan | 11217 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan | Taiwan |
| Taipei Medical University Hospital | Recruiting | Taipei | Taiwan | Taiwan |