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

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.

Official 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

Conditions
-----------------
Sinonasal Carcinoma, HPV-Related Squamous Cell Carcinoma

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Patients with a confirmed diagnosis of sinonasal cancer. | |
| Controls<br>Patients being seen for benign conditions at Johns Hopkins. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV Status | High risk HPV present or absent in tumor | Collected at time of surgery or previously conducted biopsy | 

Secondary Outcome Measures

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