The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan

Recruiting

• Conditions: Oropharyngeal Squamous Cell Carcinoma

• Registration Number: NCT05522881
• Lead Sponsor: National Health Research Institutes, Taiwan

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.

Detailed Description

In the past decade, next-generation sequencing (NGS) technology has enabled cancer genome sequencing in screening and searching for new cancer genes in an efficient manner. This massive sequencing technique not only help to identify new altered genes for novel biomarker development, but also reveal gene alterations sensitive or resistant to specific therapies. Because the difference of genomic profiling between Taiwanese HPV positive and negative OPSCC is not clear yet, we propose this multi-center research project to address this issue. In this study, we will collect tumor tissues and clinical information from patients with OPSCC and create a platform for data storage and sharing.

Study Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Study Start: 2022-11-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2029-12-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 410

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To enroll a total of 300 patients with OPSCC who fit the criteria of this study in the enrolled period	5 years of proposed observation period	To enroll a total of 300 patients with OPSCC who fit the criteria of this study in the enrolled period

Secondary Outcome Measures

Name	Time	Method
To compare the difference of the genetic and molecular profiles among patients with HPV positive and negative OPSCC	5 years of proposed observation period	To compare the difference of the genetic and molecular profiles among patients with HPV positive and negative OPSCC
To compare the difference of genetic and molecular profiles between early (stage I and II) and advanced stage (stage III and IV) of HPV positive OPSCC	5 years of proposed observation period	To compare the difference of genetic and molecular profiles between early (stage I and II) and advanced stage (stage III and IV) of HPV positive OPSCC
To perform next generation sequencing analysis of OPSCC tumor tissues	5 years of proposed observation period	To perform next generation sequencing analysis of OPSCC tumor tissues
Collect clinical data of OPSCC	5 years of proposed observation period	To correlate with the clinical characteristics and treatment outcomes of patients with the genetic profile in Taiwan.

Trial Locations

Locations (7)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Pei-Jen Alex Lou; 🇨🇳 Taipei, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan