Actively Recruiting
A Prospective Observational Study to Explore HLA-A*02:01 Allele Frequency and NY-ESO-1 Expression in Cancer Patients in Taiwan
Led by PharmaEssentia · Updated on 2025-07-30
1200
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the frequency of the HLA-A*02:01 allele and the expression of NY-ESO-1 in cancer patients within the Taiwanese population. This observational study focuses on patients with specific solid tumors including triple-negative breast cancer, hepatocellular carcinoma, head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma), lung squamous cell carcinoma, synovial sarcoma, esophageal squamous cell carcinoma, cervical cancer, and ovarian cancer. The study aims to better understand the prevalence of these genetic and protein markers that may be relevant for future therapeutic strategies. Participants will undergo high-resolution genotyping to identify the presence of the HLA-A*02:01 allele and immunohistochemistry (IHC) testing to detect NY-ESO-1 expression in tumor samples. Tumor samples may be fresh or archival tissue. The study includes patients who have received standard curative or palliative therapies or who have advanced tumors with no accepted therapies left. There is no intervention or treatment given as this is an observational study. During the study, researchers will collect data on the genetic and protein expression status of participants' tumors and analyze this information by tumor type and across the pooled patient population. Tumor samples and patient clinical information will be assessed once. The main outcomes measured are the frequency of the HLA-A*02:01 allele and the prevalence of NY-ESO-1 positive expression among patients. The study is designed to last until the end of 2025 and involves a single day of assessment per participant.
CONDITIONS
Brief Title
HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign an informed consent form.
- Adult aged 18 years or older at the time of consent.
- Confirmed diagnosis of one of the following solid tumors: head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma), hepatocellular carcinoma, lung squamous cell carcinoma, synovial sarcoma, triple-negative breast cancer, esophageal squamous cell carcinoma, cervical cancer, or ovarian cancer.
- Received standard curative or palliative therapy including targeted therapy, or have advanced tumors without accepted or effective therapies.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 1 or less.
- Body weight of at least 50 kilograms.
- Life expectancy of at least 6 months.
- Agree to provide tumor sample for NY-ESO-1 immunohistochemistry staining from fresh or archival tissue.
You will not qualify if you...
- Known primary immunodeficiency such as Severe Combined Immunodeficiency Disease or AIDS.
- Uncontrolled illnesses unsuitable for enrollment, including active infections, symptomatic heart failure, unstable angina, unstable arrhythmia, psychiatric illness, or social conditions limiting study compliance.
- Diagnosis of two or more active cancers; only one targeted tumor allowed unless the other cancer was cured with over 6 months disease-free.
- Untreated or symptomatic brain metastasis.
- History of organ or allogeneic stem cell transplantation.
- Prior use of any cell therapy or other conditions deemed unsuitable by the investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo high resolution genotyping for HLA-A*02:01 and NY-ESO-1 expression status using immunohistochemistry staining on tumor samples.
1 visit (in-person)
Duration - Up to study completion date
Participants who undergo routine care are observed to analyze the frequency of HLA-A*02:01 allele and prevalence of NY-ESO-1 positive expression.
Participants are not required to attend additional visits for the study beyond routine care
Trial Site Locations
Total: 6 locations
1
Chang Gung Memorial Hospital, Chiayi Branch
Chiayi City, Taiwan, Taiwan
Actively Recruiting
2
Taichung Veterans General Hospital
Taichung, Taiwan, Taiwan, 407219
Actively Recruiting
3
National Cheng Kung University Hospital
Tainan, Taiwan, Taiwan, 704
Actively Recruiting
4
Taipei Veterans General Hospital
Taipei, Taiwan, Taiwan, 11217
Actively Recruiting
5
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Actively Recruiting
6
Taipei Medical University Hospital
Taipei, Taiwan, Taiwan
Actively Recruiting
Research Team
H
Hsi-Chi Chang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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