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

Recruiting

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

• Registration Number: NCT04979000
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-23
• Study First Posted: 2021-07-27
• Study Start: 2021-08-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26
• Primary Completion: 2026-01-30
• Study Completion: 2028-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 499

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HPV Status	Collected at time of surgery or previously conducted biopsy	High risk HPV present or absent in tumor

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States