The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan
NCT ID: NCT05522881
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
410 participants
OBSERVATIONAL
2022-11-25
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
reference subgroup
60 patients with head and neck SCC (excluding OPSCC)
No interventions assigned to this group
recurrence subgroup
pairs of primary and recurrent tumors (at the first distal or local recurrence) of head and neck SCC
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
China Medical University Hospital
OTHER
Taichung Veterans General Hospital
OTHER
National Cheng-Kung University Hospital
OTHER
Kaohsiung Veterans General Hospital.
OTHER
Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
National Health Research Institutes, Taiwan
OTHER
Responsible Party
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Principal Investigators
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Pei-Jen Lou, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Shang-Hung Chen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Health Research Institutes, Taiwan
Locations
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Pei-Jen Alex Lou
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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T1322
Identifier Type: -
Identifier Source: org_study_id
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