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

HPV-Related Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979000
• Other study ID #: J20108
• Status: Recruiting
• Start date: August 3, 2021
• Est. completion date: January 30, 2028

Study information

• Verified date: August 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Nyall London, M.D.
• Phone: 301-896-3332
• Email: nlondon2[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 499
• Est. completion date: January 30, 2028
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• HPV-Related Squamous Cell Carcinoma
• Sinonasal Carcinoma

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV Status	High risk HPV present or absent in tumor	Collected at time of surgery or previously conducted biopsy
Secondary	Gender Differences	Gender differences in HPV-HNSCC risk factors (tobacco, alcohol, drug use and sexual behavior).	completion of the study, approximately 2 years
Secondary	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