The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan

Conditions
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Oropharyngeal Squamous Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 20 and above Pathological reported as squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula) Available p16 immunohistochemical staining status Willingness to provide archival or newly obtained tumor tissues for current study proposal Life expectancy more than 3 months Patients fully understand the protocol with the willingness to have regular follow-up Exclusion criteria Inability to cooperate by providing a complete medical history No available tumor tissues for genetic testing Undesirable compliance 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HPV positive-Post treatment<br>The subject has received any anti-cancer treatment with pathological report of squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula) and positive p16 immunohistochemical staining. | |
| HPV negative-Post treatment<br>The subject has received any anti-cancer treatment with pathological report of squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula) and negative p16 immunohistochemical staining. | |
| HPV positive-Treatment-naïve<br>The subject has received no anti-cancer treatment with pathological report of squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula) and positive p16 immunohistochemical staining. | |
| HPV negative-Treatment-naïve<br>The subject has received no anti-cancer treatment with pathological report of squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula) and negative p16 immunohistochemical staining. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To enroll a total of 300 patients with OPSCC who fit the criteria of this study in the enrolled period | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To perform next generation sequencing analysis of OPSCC tumor tissues | To perform next generation sequencing analysis of OPSCC tumor tissues | 5 years of proposed observation period | 
| Collect clinical data of OPSCC | To correlate with the clinical characteristics and treatment outcomes of patients with the genetic profile in Taiwan. | 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 the genetic and molecular profiles among patients with HPV positive and negative 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human papillomavirus, oropharyngeal squamous cell carcinoma, next-generation sequencing, precision medicine