The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan

Oropharyngeal Squamous Cell Carcinoma Clinical Trial

Official title:

The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05522881
• Other study ID #: T1322
• Status: Recruiting
• Start date: November 25, 2022
• Est. completion date: December 30, 2029

Study information

• Verified date: November 2023
• Source: National Health Research Institutes, Taiwan
• Contact: Shang-Hung Chen, MD.PhD
• Phone: 886 (06) 7000123
• Email: bryanchen[@]nhri.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2029
• Est. primary completion date: December 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Ages 20 and above

2. Pathological reported as squamous cell carcinoma of oropharynx (soft palate, tonsil, base of tongue, pharyngeal wall, uvula or vallecula)

3. Available p16 immunohistochemical staining status

4. Willingness to provide archival or newly obtained tumor tissues for current study proposal

5. Life expectancy more than 3 months

6. 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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Oropharyngeal Neoplasms
• Oropharyngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
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

Sponsors (7)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	China Medical University Hospital, Kaohsiung Veterans General Hospital., National Cheng-Kung University Hospital, National Taiwan University Hospital, Taichung Veterans General Hospital, Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years of proposed observation period
Secondary	To perform next generation sequencing analysis of OPSCC tumor tissues	To perform next generation sequencing analysis of OPSCC tumor tissues	5 years of proposed observation period
Secondary	Collect clinical data of OPSCC	To correlate with the clinical characteristics and treatment outcomes of patients with the genetic profile in Taiwan.	5 years of proposed observation period
Secondary	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	5 years of proposed observation period
Secondary	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	5 years of proposed observation period