Oropharyngeal Squamous Cell CarcinomaNCT05522881
The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan
An observational study of Oropharyngeal Squamous Cell Carcinoma, run by National Health Research Institutes, Taiwan at 7 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma
- How many people
- 410 participants
- Where
- 7 sitesTaiwan
- Study dates
- 25 Nov 2022to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To enroll a total of 410 patients with head and neck SCC
Who may be able to join
- Ages 20 and above
- Pathological reported as squamous cell carcinoma of head and neck
- Available p16 immunohistochemical staining status (restricted to the OPSCC subgroup)
- Participants have both archival tumor tissues from the primary head and neck SCC and from the first recurrent tumor (for the recurrence subgroup)
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Taiwan7 sites, 7 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Li-Tzong Chen, MD, leochen@nhri.org.tw
Li-Tzong Chen, MD
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City
Bor-Hwang KANG, M.D., bhkang@vghks.gov.tw
Bor-Hwang KANG, M.D.
- Recruiting
China Medical University Hospital
Taichung, 400
Chun-Hung Hua Bai, MD, entmanhua@gmail.com
Chun-Hung Hua, MD
- Recruiting
Taichung Veterans General Hospital
Taichung
Chen-Chi Wang, M.D., entccwang@msn.com
Chen-Chi Wang, M.D.
- Recruiting
National Cheng Kung University Hospital
Tainan
Jenn-Ren Hsiao, MD,PhD, hsiaojr@mail.ncku.edu.tw
Jenn-Ren Hsiao, MD,PhD
- Recruiting
Pei-Jen Alex Lou
Taipei
Pei-Jen Lou, MD, PhD, pjlou@ntu.edu.tw
Pei-Jen A Lou, MD, PhD
- Recruiting
Taipei Veterans General Hospital
Taipei
Pen-Yuan Chu, MD, pychu@vghtpe.gov.tw
Pen-Yuan Chu, MD
About this study
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.
Read the 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.
- Conditions
- Oropharyngeal Squamous Cell Carcinoma
- Keywords
- human papillomavirus, oropharyngeal squamous cell carcinoma, next-generation sequencing, precision medicine
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | pairs of primary and recurrent tumors (at the first distal or local recurrence) of head and neck SCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years of proposed observation period
Secondary outcomes (4)
To perform next generation sequencing analysis of OPSCC tumor tissues
To perform next generation sequencing analysis of OPSCC tumor tissues
Measured: 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.
Measured: 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
Measured: 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
Measured: 5 years of proposed observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start25 Nov 2022
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Pei-Jen Lou, MD, PhD, Principal investigator, National Taiwan University HospitalShang-Hung Chen, MD, PhD, Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522881
- Sponsor's protocol ID
- T1322
- Status last verified
- Jun 2026
- First submitted
- 23 Aug 2022
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan
- ClinicalTrials.gov ID
- NCT05522881
- Acronym / sponsor ID
- T1322
- Conditions
- Oropharyngeal Squamous Cell Carcinoma
- Keywords
- human papillomavirus, oropharyngeal squamous cell carcinoma, next-generation sequencing, precision medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- 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 start
- 25 Nov 2022 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 | – | –pairs of primary and recurrent tumors (at the first distal or local recurrence) of head and neck SCC |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To enroll a total of 410 patients with head and neck SCC
Key inclusion criteria (8 listed)
- Ages 20 and above
- Pathological reported as squamous cell carcinoma of head and neck
- Available p16 immunohistochemical staining status (restricted to the OPSCC subgroup)
- Participants have both archival tumor tissues from the primary head and neck SCC and from the first recurrent tumor (for the recurrence subgroup)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To enroll a total of 300 patients with OPSCC who fit the criteria of this study in the enrolled period
Time frame: 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
4 secondary outcomes
To perform next generation sequencing analysis of OPSCC tumor tissues
Time frame: 5 years of proposed observation period
Collect clinical data of OPSCC
Time frame: 5 years of proposed observation period
To compare the difference of the genetic and molecular profiles among patients with HPV positive and negative OPSCC
Time frame: 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
Time frame: 5 years of proposed observation period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pei-Jen Lou, MD, PhD principal investigator
National Taiwan University Hospital
Shang-Hung Chen, MD, PhD principal investigator
National Health Research Institutes, Taiwan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Squamous Cell Carcinoma, run by National Health Research Institutes, Taiwan at 7 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shang-Hung Chen, MD.PhD (886 (06) 7000123 ext. 65113, bryanchen@nhri.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To enroll a total of 300 patients with OPSCC who fit the criteria of this study in the enrolled period (time frame: 5 years of proposed observation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.