Oropharyngeal Squamous Cell Carcinoma
Conditions
Keywords
human papillomavirus, oropharyngeal squamous cell carcinoma, next-generation sequencing, precision medicine
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.
Interventions
None listed
Sponsors
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
China Medical University Hospital
Taichung Veterans General Hospital
National Cheng-Kung University Hospital
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
Taiwan
Contacts
CONTACTShang-Hung Chen, MD.PhD
CONTACTPei-Jen Lou, MD, PhD
PRINCIPAL_INVESTIGATORPei-Jen Lou, MD, PhD
National Taiwan University Hospital
PRINCIPAL_INVESTIGATORShang-Hung Chen, MD, PhD
National Health Research Institutes, Taiwan
Outcome results
None listed