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

RECRUITINGSponsored by H. Lee Moffitt Cancer Center and Research Institute
Actively Recruiting
SponsorH. Lee Moffitt Cancer Center and Research Institute
Started2024-01-22
Est. completion2029-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

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).

Eligibility

Age: 18 Years+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

Conditions3

CancerHPV-Related CarcinomaOropharyngeal Cancer

Locations2 sites

Florida

1 site
Moffitt Cancer Center
Tampa, Florida, 33612
Kimberly Isaacs-Soriano813-745-6992kimberly.Isaacs-Soriano@moffitt.org

Pennsylvania

1 site
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Jose P. Zevallos, MD, PhDzevallosjp@upmc.edu

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