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NCT Number: NCT05522881

The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan

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.

Recruiting

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. To perform next generation sequencing analysis of OPSCC tumor tissues

    Time frame: 5 years of proposed observation period

    To perform next generation sequencing analysis of OPSCC tumor tissues

  2. Collect clinical data of OPSCC

    Time frame: 5 years of proposed observation period

    To correlate with the clinical characteristics and treatment outcomes of patients with the genetic profile in Taiwan.

  3. 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 the genetic and molecular profiles among patients with HPV positive and negative OPSCC

  4. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Pei-Jen Lou, MD, PhD

CONTACT

[email protected]

886 (02) 23123456 ext. 65224

Shang-Hung Chen, MD.PhD

CONTACT

[email protected]

886 (06) 7000123 ext. 65113

Sponsors and collaborators

Lead sponsor

National Health Research Institutes, Taiwan

Other

Collaborators

  • China Medical University Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung Veterans General Hospital.
  • National Cheng-Kung University Hospital
  • National Taiwan University Hospital
  • Taichung Veterans General Hospital
  • Taipei Veterans General Hospital, Taiwan

Registry information

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Aug 31, 2022
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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