Using biomarkers to detect early HPV-related throat cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of a combined HPV 16 DNA and host gene methylation oral biomarker panel in distinguishing early-stage oropharyngeal cancer (OPC) from controls. The study will involve 100 early and 100 late-stage OPC cases, along with 200 matched controls based on sex, age, race/ethnicity, and tobacco use. Participants will be recruited from the Moffitt Cancer Center and the University of Pittsburgh Medical Center, focusing on newly diagnosed patients who have not yet received treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting
• University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Anna Giuliano, PhD — Moffitt Cancer Center
• Study coordinator: Kimberly Isaacs-Soriano
• Email: kimberly.Isaacs-Soriano@moffitt.org
• Phone: 813-745-6992

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.