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

H. Lee Moffitt Cancer Center and Research Institute · with National Institutes of Health (NIH) · NCT06305676

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
400
US sites recruiting
3
Study start
January 22, 2024
Record last updated
September 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: combined HPV 16 DNA and host gene methylation oral biomarker panel

Conditions: Oropharyngeal Cancer; HPV-Related Carcinoma

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Moffitt Cancer Center

    Tampa, FL 33612

    Site contact: Kimberly Isaacs-Soriano · 813-745-6992 · kimberly.Isaacs-Soriano@moffitt.org

  • University of Nebraska Medical Center

    Omaha, NE 68198

  • University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

    Pittsburgh, PA 15232

    Site contact: Jose P. Zevallos, MD, PhD · zevallosjp@upmc.edu

Study contacts (from the official record)

  • Kimberly Isaacs-Soriano · 813-745-6992 · kimberly.Isaacs-Soriano@moffitt.org
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Biomarker Approach to Screening for the Early Detection of… (NCT06305676) | Bored Studies