Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
NCT ID: NCT06305676
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2024-01-22
2029-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case Group
Case group will consist of early and late disease pre-treatment Oropharyngeal Cancer cases.
combined HPV 16 DNA and host gene methylation oral biomarker panel
DNA Methylation Profiling
Control Group
Controls will be enrolled from members of the catchment area to ensure geographic comparability of cases and controls. Controls will be matched by sex, age, race/ethnicity, and tobacco use.
combined HPV 16 DNA and host gene methylation oral biomarker panel
DNA Methylation Profiling
Interventions
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combined HPV 16 DNA and host gene methylation oral biomarker panel
DNA Methylation Profiling
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Anna Giuliano, PhD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Antonio Amelio, PhD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Kimberly Isaacs-Soriano
Role: primary
Jose P. Zevallos, MD, PhD
Role: primary
Robert Ferris, PhD
Role: backup
Other Identifiers
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MCC-23073
Identifier Type: -
Identifier Source: org_study_id