The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• To enroll a total of 300 patients with OPSCC who fit the criteria of this study in the enrolled period [Срок оценки: 5 years of proposed observation period]

Вторичные конечные точки (4)

• To perform next generation sequencing analysis of OPSCC tumor tissues [Срок оценки: 5 years of proposed observation period]
• Collect clinical data of OPSCC [Срок оценки: 5 years of proposed observation period]
• To compare the difference of the genetic and molecular profiles among patients with HPV positive and negative OPSCC [Срок оценки: 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 [Срок оценки: 5 years of proposed observation period]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Тайвань · 7 центров

• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
• Kaohsiung Veterans General Hospital — Kaohsiung City
• China Medical University Hospital — Taichung
• Taichung Veterans General Hospital — Taichung
• National Cheng Kung University Hospital — Tainan
• Pei-Jen Alex Lou — Taipei
• Taipei Veterans General Hospital — Taipei

Идентификаторы

NCT: NCT05522881 · T1322

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗