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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06305676

Acronym

BASH OPC

Enrollment

400

Registered

2024-03-12

Start date

2024-01-22

Completion date

2029-01-01

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV-Related Carcinoma, Oropharyngeal Cancer

Keywords

Oropharyngeal Cancer, Early Detection, Screening

Brief 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).

Interventions

DIAGNOSTIC_TESTcombined HPV 16 DNA and host gene methylation oral biomarker panel

DNA Methylation Profiling

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic Sensitivity	Up to 60 months	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.
Diagnostic Specificity	Up to 60 months	A 95% one-sided confidence interval using the Wilson method will be obtained for Specificity based on the control patients.

Countries

United States

Contacts

CONTACTKimberly Isaacs-Soriano

kimberly.Isaacs-Soriano@moffitt.org813-745-6992

PRINCIPAL_INVESTIGATORAnna Giuliano, PhD

Moffitt Cancer Center

PRINCIPAL_INVESTIGATORAntonio Amelio, PhD