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

NCT06305676 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-02-09

No results posted yet for this study

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).

Conditions

  • Oropharyngeal Cancer
  • HPV-Related Carcinoma

Interventions

DIAGNOSTIC_TEST

combined HPV 16 DNA and host gene methylation oral biomarker panel

DNA Methylation Profiling

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Anna Giuliano, PhD · Moffitt Cancer Center

  • Antonio Amelio, PhD · Moffitt Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2029-01-31
Completion
2029-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06305676 on ClinicalTrials.gov