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| Name | Class |
|---|---|
| National Taiwan University Hospital | OTHER |
| Taipei Veterans General Hospital, Taiwan | OTHER_GOV |
| China Medical University Hospital | OTHER |
| Taichung Veterans General Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV positive-Post treatment | 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 | 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 | 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 | 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. | ||
| reference subgroup | 60 patients with head and neck SCC (excluding OPSCC) | ||
| recurrence subgroup |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion criteria
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To enroll a total of 410 patients with head and neck SCC
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shang-Hung Chen, MD.PhD | Contact | 886 (06) 7000123 | 65113 | bryanchen@nhri.edu.tw |
| Pei-Jen Lou, MD, PhD | Contact | 886 (02) 23123456 | 65224 | pjlou@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Pei-Jen Lou, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Shang-Hung Chen, MD, PhD | National Health Research Institutes, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | Taiwan |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| OTHER |
| National Cheng-Kung University Hospital | OTHER |
| Kaohsiung Veterans General Hospital. | OTHER |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | OTHER |
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One H&E-stained slide, and at least 10 unstained tissue on non-coated slides (5 um thickness) for cancer panel-based NGS analysis.20 unstained tissue on non-coated slides (4 um thickness) will be required for HPV genotyping testing.
20 ml Cell-Free DNA blood will be collected from the subjects within two weeks of the study registration. Of the treatment-naïve group, 20 ml blood specimens will be additionally collected at week 4 and 8 after the curative therapy is completed then every 6 months until the study withdrawal or tumor recurrence. For all subjects receiving the curative therapy, 20 ml of blood specimen will be collected when tumor recurrence is diagnosed at follow-up after the study registration.
pairs of primary and recurrent tumors (at the first distal or local recurrence) of head and neck SCC |
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 |
| Kaohsiung Veterans General Hospital | Recruiting | Kaohsiung City | Taiwan |
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| China Medical University Hospital | Recruiting | Taichung | 400 | Taiwan |
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| Taichung Veterans General Hospital | Recruiting | Taichung | Taiwan |
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| National Cheng Kung University Hospital | Recruiting | Tainan | Taiwan |
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| Pei-Jen Alex Lou | Recruiting | Taipei | Taiwan |
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| Taipei Veterans General Hospital | Recruiting | Taipei | Taiwan |
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| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |