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NCT06305676 | RECRUITING | Oropharyngeal Cancer

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

H. Lee Moffitt Cancer Center and Research Institute

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).

Condition or disease

Oropharyngeal Cancer

HPV-Related Carcinoma

Intervention/treatment

combined HPV 16 DNA and host gene methylation oral biomarker panel

Study Type : OBSERVATIONAL
Estimated Enrollment : 400 participants
Official Title : Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
Actual Study Start Date : 2024-01-22
Estimated Primary Completion Date : 2029-01
Estimated Study Completion Date : 2029-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)

Location Details

NCT06305676

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How to Participate

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Locations

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612

RECRUITING

United States, Pennsylvania

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232