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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06305676
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • combined HPV 16 DNA and host gene methylation oral biomarker panel — DIAGNOSTIC_TEST
    DNA Methylation Profiling

Study Details

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).

Key Dates

Start date
Jan 22, 2024
Status verified
Feb 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Case Group
    Case group will consist of early and late disease pre-treatment Oropharyngeal Cancer cases.
  • Arm: 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.

Primary Outcome Measure

Diagnostic Sensitivity [ Time Frame: Up to 60 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Kimberly Isaacs-Soriano
[email protected]
813-745-6992
Anna Giuliano, PhD (PRINCIPAL_INVESTIGATOR)
Antonio Amelio, PhD (PRINCIPAL_INVESTIGATOR)
Jimmy Caudell, MD, PhD (SUB_INVESTIGATOR)
Christine Chung, MD (SUB_INVESTIGATOR)
Bruce Wenig, MD (SUB_INVESTIGATOR)
University of Pittsburgh Medical Center (UPMC) Hillman Cancer CenterPittsburghPennsylvania15232
Jose P. Zevallos, MD, PhD
[email protected]
Robert Ferris, PhD
[email protected]

Find similar trials in Tampa, FL

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Moffitt Cancer Center· Tampa, FLUniversity of Pittsburgh Medical Center (UPMC) Hillman Cancer Center· Pittsburgh, PA

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