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NCT06305676 Clinical Trial

Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)

Oropharyngeal Cancer Clinical Trial

— BASH OPC  

Official title:
Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06305676
Other study ID # MCC-23073
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 22, 2024
Est. completion date January 2029

Study information
Verified date March 2024
Source H. Lee Moffitt Cancer Center and Research Institute
Contact Kimberly Isaacs-Soriano
Phone 813-745-6992
Email kimberly.Isaacs-Soriano@moffitt.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date January 2029
Est. primary completion date January 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Cases: - Aged at least 18 years - Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV) - Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks - Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center - Aged at least 35 years - Have no previous diagnosis of HNC or HPV-related cancer - Fully understands study procedures - Voluntarily agrees to participate by giving written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center Exclusion Criteria: - Not meeting all of the above inclusion criteria for either the case or control group

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• combined HPV 16 DNA and host gene methylation oral biomarker panel
DNA Methylation Profiling

Locations
Country Name City State
United States University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center Pittsburgh Pennsylvania
United States Moffitt Cancer Center Tampa Florida

Sponsors (2)
Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic Sensitivity A 95% one-sided confidence interval using the Wilson method will be obtained for sensitivity for the early Oropharyngeal Cancer cases and late Oropharyngeal Cancer cases. Up to 60 months
Primary Diagnostic Specificity A 95% one-sided confidence interval using the Wilson method will be obtained for Specificity based on the control patients. Up to 60 months
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