NCT05522881 The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan
| NCT ID | NCT05522881 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Health Research Institutes, Taiwan |
| Condition | Oropharyngeal Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 410 participants |
| Start Date | 2022-11-25 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 410 participants in total. It began in 2022-11-25 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
We will use the next-generation sequencing (NGS) technology to identify genomic alterations of Taiwanese HPV positive and negative oropharyngeal squamous cell carcinoma (OPSCC) for novel biomarker development and the study design of potential clinical trials or translational research.
Eligibility 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
Contact & Investigator
Pei-Jen Lou, MD, PhD
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT05522881 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Oropharyngeal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05522881 currently recruiting?
Yes, NCT05522881 is actively recruiting participants. Contact the research team at bryanchen@nhri.edu.tw for enrollment information.
Where is the NCT05522881 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan, Kaohsiung City, Taiwan, Taichung, Taiwan, Taichung, Taiwan and 3 additional locations.
Who is sponsoring the NCT05522881 clinical trial?
NCT05522881 is sponsored by National Health Research Institutes, Taiwan. The principal investigator is Pei-Jen Lou, MD, PhD at National Taiwan University Hospital. The trial plans to enroll 410 participants.