The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorNational Health Research Institutes, Taiwan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 population
To enroll a total of 410 patients with head and neck SCC
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
410 Participants
are grouped into 6 trial groups6
Trial groupsSee each trial group below.
Group A: HPV positive-Post treatment
Group B: HPV negative-Post treatment
Group C: HPV positive-Treatment-naïve
Group D: HPV negative-Treatment-naïve
Group E: reference subgroup
Group F: recurrence subgroup
Trial outcomes
Primary outcomes
1
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
Time frame
5 years of proposed observation periodSecondary outcomes
1
To perform next generation sequencing analysis of OPSCC tumor tissues
To perform next generation sequencing analysis of OPSCC tumor tissues
Time frame
5 years of proposed observation period2
Collect clinical data of OPSCC
To correlate with the clinical characteristics and treatment outcomes of patients with the genetic profile in Taiwan.
Time frame
5 years of proposed observation period3
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
Time frame
5 years of proposed observation period4
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
Time frame
5 years of proposed observation periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Health Research Institutes, Taiwan
Lead sponsor
National Taiwan University Hospital
Collaborator
Taipei Veterans General Hospital, Taiwan
Collaborator
China Medical University Hospital
Collaborator
Taichung Veterans General Hospital
Collaborator
National Cheng-Kung University Hospital
Collaborator
Kaohsiung Veterans General Hospital.
Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborator
Source ClinicalTrials.gov