Trial Title:
The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan
NCT ID:
NCT05522881
Condition:
Oropharyngeal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
human papillomavirus
oropharyngeal squamous cell carcinoma
next-generation sequencing
precision medicine
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Criteria for eligibility:
Study pop:
To enroll a total of 400 patients with head and neck SCC
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Li-Tzong Chen, MD
Email:
leochen@nhri.org.tw
Investigator:
Last name:
Li-Tzong Chen, MD
Email:
Principal Investigator
Investigator:
Last name:
Che-Wei Wu, MD
Email:
Sub-Investigator
Investigator:
Last name:
Leong-Perng Chan, MD
Email:
Sub-Investigator
Investigator:
Last name:
Yi-Chu Lin, MD
Email:
Sub-Investigator
Investigator:
Last name:
Tzu-Yen Huang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jia Joanna Wang, MD
Email:
Sub-Investigator
Investigator:
Last name:
How-Yun Ko, MD
Email:
Sub-Investigator
Investigator:
Last name:
Hui-Ching Wang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Tsung-Jang Yeh, MD
Email:
Sub-Investigator
Investigator:
Last name:
Tzer-Ming Chuang, MD
Email:
Sub-Investigator
Facility:
Name:
Kaohsiung Veterans General Hospital
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Bor-Hwang KANG, M.D.
Email:
bhkang@vghks.gov.tw
Investigator:
Last name:
Bor-Hwang KANG, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Ching-Chih Lee, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Hsing-Hao SU, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Kuo-Ping Chang, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Ting-Shou Chang, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Yu-His Liu, M.D.
Email:
Sub-Investigator
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Zip:
400
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chun-Hung Hua Bai, MD
Email:
entmanhua@gmail.com
Investigator:
Last name:
Chun-Hung Hua, MD
Email:
Principal Investigator
Investigator:
Last name:
Ching-Yun Hsieh, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ming-Yu Lien, MD
Email:
Sub-Investigator
Investigator:
Last name:
Hsiu-San Hsu, MD
Email:
Sub-Investigator
Investigator:
Last name:
Chun-Yu Lai, MD
Email:
Sub-Investigator
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chen-Chi Wang, M.D.
Email:
entccwang@msn.com
Investigator:
Last name:
Chen-Chi Wang, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Yi-Chun Liu, M.D.
Email:
Sub-Investigator
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Jenn-Ren Hsiao, MD,PhD
Email:
hsiaojr@mail.ncku.edu.tw
Investigator:
Last name:
Jenn-Ren Hsiao, MD,PhD
Email:
Principal Investigator
Investigator:
Last name:
Chun-Yen Ou, MD
Email:
Sub-Investigator
Investigator:
Last name:
Wei-Ting Lee, MD
Email:
Sub-Investigator
Investigator:
Last name:
Chan-Chi Chang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Yuan-Hua Wu, MD
Email:
Sub-Investigator
Investigator:
Last name:
Shang-Yin Wu, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Shang-Hung Chen, MD,PhD
Email:
Sub-Investigator
Investigator:
Last name:
Hui-Jen Tsai, MD,PhD
Email:
Sub-Investigator
Investigator:
Last name:
Yung-Yeh Su, MD
Email:
Sub-Investigator
Investigator:
Last name:
Kwang-Yu Chang, MD,PhD
Email:
Sub-Investigator
Investigator:
Last name:
Chia-Jui Yen, MD,PhD
Email:
Sub-Investigator
Facility:
Name:
Pei-Jen Alex Lou
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Pei-Jen Lou, MD, PhD
Email:
pjlou@ntu.edu.tw
Investigator:
Last name:
Pei-Jen A Lou, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Yang Tsung-Lin, MD
Email:
Sub-Investigator
Investigator:
Last name:
Cheng-Ping Wang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Tseng-Cheng Chen, MD
Email:
Sub-Investigator
Investigator:
Last name:
Chun-Nan Chen, MD
Email:
Sub-Investigator
Investigator:
Last name:
Yung-Ming Jeng, MD
Email:
Sub-Investigator
Investigator:
Last name:
Mei-Chun Lin, MD
Email:
Sub-Investigator
Investigator:
Last name:
Hsin-Lin Chen, MD
Email:
Sub-Investigator
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Pen-Yuan Chu, MD
Email:
pychu@vghtpe.gov.tw
Investigator:
Last name:
Pen-Yuan Chu, MD
Email:
Principal Investigator
Investigator:
Last name:
Muh-Hwa Yang, MD,Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Shyh-Kuan Tai, MD
Email:
Sub-Investigator
Investigator:
Last name:
Tsung-Lun Lee, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ying-Ju Kuo, MD
Email:
Sub-Investigator
Start date:
November 25, 2022
Completion date:
December 30, 2029
Lead sponsor:
Agency:
National Health Research Institutes, Taiwan
Agency class:
Other
Collaborator:
Agency:
National Taiwan University Hospital
Agency class:
Other
Collaborator:
Agency:
Taipei Veterans General Hospital, Taiwan
Agency class:
Other
Collaborator:
Agency:
China Medical University Hospital
Agency class:
Other
Collaborator:
Agency:
Taichung Veterans General Hospital
Agency class:
Other
Collaborator:
Agency:
National Cheng-Kung University Hospital
Agency class:
Other
Collaborator:
Agency:
Kaohsiung Veterans General Hospital.
Agency class:
Other
Source:
National Health Research Institutes, Taiwan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05522881
