HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan
ConditionSolid Tumor Malignancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPharmaEssentia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma;
Hepatocellular carcinoma;
Disqualifiers
Known primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or AIDS).
Uncontrolled intercurrent illness which is not suitable for enrollment at the discretion of the investigator, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements.
Currently confirmed diagnosis of at least 2 active cancers; patient who was cured of the other cancer [disease free period > 6 months] and currently has only one research targeted tumor can be enrolled.
Untreated or symptomatic brain metastasis.
Trial population
Adult patients with confirmed diagnosis of any of the following solid tumor: 1. Head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma; 2. Hepatocellular carcinoma; 3. Lung squamous cell carcinoma; 4. Synovial sarcoma; 5. Triple-negative breast cancer; 6. Esophageal squamous cell carcinoma; 7. Cervical cancer; 8. Ovarian cancer
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
1 day2
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.
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov