NCT04979000CompletedNot Applicable
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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 site in 1 country49 target enrollmentStarted: August 3, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- HPV Status
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
HPV Status
Time Frame: Collected at time of surgery or previously conducted biopsy
High risk HPV present or absent in tumor
Secondary Outcomes
- Race/Ethnicity Differences(completion of the study, approximately 2 years)
- Gender Differences(completion of the study, approximately 2 years)
Investigators
Study Sites (1)
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