HPV in Sinonasal Ca: Retrospective Analysis Association of Human Papilloma Virus (HPV) Serology and Behavioral Risk Factors

NCT04979000 | Completed DMC

• 2 other identifiers: J20108IRB00270617
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sinonasal Carcinoma; HPV-Related Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• HPV Status

  High risk HPV present or absent in tumor

  Collected at time of surgery or previously conducted biopsy

Secondary Outcomes (2)

• Gender Differences

  completion of the study, approximately 2 years

• Race/Ethnicity Differences

  completion of the study, approximately 2 years

Study Arms (2)

Cases

Patients with a confirmed diagnosis of sinonasal cancer.

Controls

Patients being seen for benign conditions at Johns Hopkins.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

For cases, paraffin embedded tumor samples will be tested for HPV. The blood sample collected at baseline (both cases and controls) will be tested for HPV antibodies.

Study Officials

• Nyall London, M.D.

  Department of Otolaryngology and Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 27, 2021
• Study Start: August 3, 2021
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

US (1)