Analyzing HPV's role in sinonasal cancer and associated risk factors
The Role of High-risk HPV in Sinonasal Carcinomas: a Retrospective Tissue Analysis of the Increasing Frequency and Case-control Study to Evaluate the Association of HPV Serology and Behavioral Risk Factors
This study is trying to see how the human papillomavirus (HPV) is linked to sinonasal cancer and whether factors like gender, race, and lifestyle choices affect this connection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 499 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04979000 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between human papillomavirus (HPV) and sinonasal carcinoma, focusing on how anatomical site, gender, and race influence HPV-related head and neck squamous cell cancers (HNSCC). It will investigate the impact of behavioral risk factors such as tobacco, alcohol, and drug use on these cancers, particularly in the sinonasal cavity. The study will involve a case-control design, where patients with sinonasal cancer will be compared to matched controls based on age, gender, and race. Blood samples will be collected from participants to analyze HPV serology.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed or suspected diagnosis of sinonasal cancer.
Not a fit: Patients with medical or psychiatric conditions that impair their ability to provide informed consent or those who do not speak English may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of HPV's role in sinonasal cancer, potentially leading to improved prevention and treatment strategies.
How similar studies have performed: Other studies have explored HPV's association with head and neck cancers, indicating a growing body of evidence, but this specific focus on sinonasal carcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cases: * Patients must be 18 years of age or older with a confirmed or suspected diagnosis of sinonasal cancer * Patients must have either a routine diagnostic biopsy of primary tumor or surgical resection planned as part of routine care (to allow for the collection of tumor sample for the study) or grant access to archival material, from a previously performed biopsy. * Willing to provide 20 mL blood sample * Ability to understand and the willingness to sign a written informed consent document * Controls: * Must be 18 years of age or older within the categories of age, gender, and race needed to match cases * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Cases: * Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent * Participants who do not speak English and do not agree to use of a telephone or video interpreter will be excluded. However, if there is a hearing, literally or minor fluency issue and the participant requests assistance from a family member or the study coordinator, this individual may still enroll and receive this assistance to ensure they fully hear and understand everything being asked * Controls: * Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent * Participants who do not speak English and do not agree to use of a telephone or video interpreter will be excluded. However, if there is a hearing, literacy or minor fluency issue and the participant requests assistance from a family member or the study coordinator, this individual may still enroll and receive this assistance to ensure they fully hear and understand everything being asked * No prior diagnosis of head and neck cancer, except basal cell cancer * No previous radiation therapy of the head and neck
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Nyall London, M.D. — Department of Otolaryngology and Surgery
- Study coordinator: Nyall London, M.D.
- Email: nlondon2@jhmi.edu
- Phone: 301-896-3332
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.