Using biomarkers to detect early HPV-related throat cancer
Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
H. Lee Moffitt Cancer Center and Research Institute · NCT06305676
This study is testing a new way to use DNA and gene markers to see if they can help find early signs of throat cancer linked to HPV in newly diagnosed patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute (other) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (Tampa, Florida and 1 other locations) |
| Trial ID | NCT06305676 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, histologically confirmed squamous cell carcinoma of the oropharynx who have not received prior treatment.
Not a fit: Patients with a previous diagnosis of head and neck cancer or HPV-related cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of HPV-related oropharyngeal cancer, improving patient outcomes.
How similar studies have performed: Other studies have explored biomarker approaches for cancer detection, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tampa, Florida and 1 other locations
- Moffitt Cancer Center — Tampa, Florida, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oropharyngeal Cancer, HPV-Related Carcinoma, Early Detection, Screening