Registry of Genetic Changes in Oropharyngeal Cancer in Taiwan
The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan
This study is trying to find genetic changes in oropharyngeal cancer in Taiwanese patients to help create better treatments for both HPV positive and negative cases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 410 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Health Research Institutes, Taiwan Academic / other |
| Locations | 7 sites (Kaohsiung City and 6 other locations) |
| Trial ID | NCT05522881 on ClinicalTrials.gov |
What this trial studies
This observational study aims to utilize next-generation sequencing (NGS) technology to identify genomic alterations in oropharyngeal squamous cell carcinoma (OPSCC) among Taiwanese patients, both HPV positive and negative. By collecting tumor tissues and clinical data, the study seeks to develop novel biomarkers and inform the design of future clinical trials or translational research. The research will address the unclear differences in genomic profiling between the two OPSCC subgroups, contributing to precision medicine approaches in cancer treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 and above with a pathological diagnosis of oropharyngeal squamous cell carcinoma and available tumor tissues for genetic testing.
Not a fit: Patients who are unable to provide tumor tissues or have other malignancies requiring active treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of new biomarkers that enhance personalized treatment strategies for patients with oropharyngeal cancer.
How similar studies have performed: Other studies utilizing next-generation sequencing for cancer genomic profiling have shown promise, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ages 20 and above 2. Pathological reported as squamous cell carcinoma of head and neck 3. Available p16 immunohistochemical staining status (restricted to the OPSCC subgroup) 4. Participants have both archival tumor tissues from the primary head and neck SCC and from the first recurrent tumor (for the recurrence subgroup) 5. Recurrence status is defined as the reappearance of the disease occurring more than 6 months following curative surgery and/or chemoradiotherapy in the recurrence subgroup 6. Willingness to provide archival or newly obtained tumor tissues for current study proposal 7. Life expectancy more than 3 months 8. Patients fully understand the protocol with the willingness to have regular follow-up Exclusion criteria 1. Inability to cooperate by providing a complete medical history 2. No available tumor tissues for genetic testing 3. Undesirable compliance 4. Having a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded
Where this trial is running
Kaohsiung City and 6 other locations
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
- Kaohsiung Veterans General Hospital — Kaohsiung City, Taiwan (Recruiting)
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
- Taichung Veterans General Hospital — Taichung, Taiwan (Recruiting)
- National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
- Pei-Jen Alex Lou — Taipei, Taiwan (Recruiting)
- Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Pei-Jen Lou, MD, PhD — National Taiwan University Hospital
- Study coordinator: Shang-Hung Chen, MD.PhD
- Email: bryanchen@nhri.edu.tw
- Phone: 886 (06) 7000123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.