HPV in Sinonasal Ca: Retrospective Analysis Association of Human Papilloma Virus (HPV) Serology and Behavioral 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 is a case-control study designed to evaluate the role of anatomic site, gender and race in human papillomavirus-associated head and neck squamous cell cancers (HNSCC). We will explore the role of HPV, tobacco, alcohol and drug use, in HNSCC by tumor site with particular emphasis on the sinonasal cavity as well as differences in risk factors for HPV-positive HNSCC by gender and race.

Study Overview

• Status: Completed
• Conditions: HPV-Related Squamous Cell Carcinoma; Sinonasal Carcinoma

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Cases:

Patients with a confirmed diagnosis of sinonasal cancer, or clinical findings consistent with this diagnosis, seen in the Departments of Otolaryngology/Head and Neck Surgery, Radiation Oncology, or Medical Oncology of the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (SKCCC) or Johns Hopkins Head and Neck Surgery at Suburban Hospital are eligible for this study.

Controls:

Patients seen for benign conditions in the same Departments of Otolaryngology/Head and Neck Surgery, Radiation Oncology, and Medical Oncology at SKCCC or Suburban Hospital are eligible for enrollment as non-cancer controls in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cases; Patients with a confirmed diagnosis of sinonasal cancer.
Controls; Patients being seen for benign conditions at Johns Hopkins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV Status	High risk HPV present or absent in tumor	Collected at time of surgery or previously conducted biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender Differences	Gender differences in HPV-HNSCC risk factors (tobacco, alcohol, drug use and sexual behavior).	completion of the study, approximately 2 years
Race/Ethnicity Differences	Race/ethnicity differences in HPV-HNSCC risk factors (tobacco, alcohol, drug use and sexual behavior).	completion of the study, approximately 2 years

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Nyall London, M.D., Department of Otolaryngology and Surgery

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): May 28, 2025

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: J20108; IRB00270617 (Other Identifier: JHM IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No