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

Johns Hopkins Medicine

Status

Completed

Conditions

HPV-Related Squamous Cell Carcinoma

Sinonasal Carcinoma

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04979000

J20108

IRB00270617 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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