Clinical trial NCT05522881: The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan
Official title: The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oropharyngeal Squamous Cell Carcinoma
Keywords: human papillomavirus
oropharyngeal squamous cell carcinoma
next-generation sequencing
precision medicine
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
name: Taipei Veterans General Hospital, Taiwan
name: China Medical University Hospital
name: Taichung Veterans General Hospital
name: National Cheng-Kung University Hospital
name: Kaohsiung Veterans General Hospital.
First posted: 2022-08-31
Enrollment: 410
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To enroll a total of 410 patients with head and neck SCC

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.

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

Primary outcomes:
measure: To enroll a total of 300 patients with OPSCC who fit the criteria of this study in the enrolled period
timeFrame: 5 years of proposed observation period
Secondary outcomes:
measure: To perform next generation sequencing analysis of OPSCC tumor tissues
timeFrame: 5 years of proposed observation period
measure: Collect clinical data of OPSCC
timeFrame: 5 years of proposed observation period
measure: To compare the difference of the genetic and molecular profiles among patients with HPV positive and negative OPSCC
timeFrame: 5 years of proposed observation period
measure: 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
timeFrame: 5 years of proposed observation period
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Pei-Jen Alex Lou
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Pei-Jen Lou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Health Research Institutes, Taiwan
name: Shang-Hung Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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