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

NCT ID: NCT04979000

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-03
• Study Completion Date: 2025-05-28

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cases

Patients with a confirmed diagnosis of sinonasal cancer.

No interventions assigned to this group

Controls

Patients being seen for benign conditions at Johns Hopkins.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nyall London, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Otolaryngology and Surgery

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00270617

Identifier Type: OTHER

Identifier Source: secondary_id

J20108

Identifier Type: -

Identifier Source: org_study_id