Recruiting

Biomarker Approach

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT06305676

Conditions

Oropharyngeal Cancer

HPV-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

combined HPV 16 DNA and host gene methylation oral biomarker panel

Study Details

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).

Conditions

Oropharyngeal Cancer

HPV-Related Carcinoma

Study ID

NCT06305676

Start date

Jan 22, 2024

Status verified date

Feb, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Case Group

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

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.

Interventions

combined HPV 16 DNA and host gene methylation oral biomarker panel

DNA Methylation Profiling

Primary outcome measure

  • Diagnostic Sensitivity [ Time Frame: Up to 60 months ]
  • Diagnostic Specificity [ Time Frame: Up to 60 months ]

Central Contacts and Locations

Central contacts

Kimberly Isaacs-Soriano

813-745-6992kimberly.Isaacs-Soriano@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Kimberly Isaacs-Soriano

813-745-6992kimberly.Isaacs-Soriano@moffitt.org

Principal Investigator:

Anna Giuliano, PhD

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Jose P. Zevallos, MD, PhD

zevallosjp@upmc.edu

Robert Ferris, PhD

ferrrl@UPMC.EDU

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • Oropharyngeal Cancer
  • Early Detection
  • Screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-02-09.