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Completed

NCT Number: NCT04979000

HPV in Sinonasal Ca: Retrospective Analysis Association of Human Papilloma Virus (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.

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Key information

Conditions

Sinonasal Carcinoma HPV-Related Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. HPV Status

    Time frame: Collected at time of surgery or previously conducted biopsy

    High risk HPV present or absent in tumor

Secondary outcomes

  1. Gender Differences

    Time frame: completion of the study, approximately 2 years

    Gender differences in HPV-HNSCC risk factors (tobacco, alcohol, drug use and sexual behavior).

  2. Race/Ethnicity Differences

    Time frame: completion of the study, approximately 2 years

    Race/ethnicity differences in HPV-HNSCC risk factors (tobacco, alcohol, drug use and sexual behavior).

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 27, 2021
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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