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History of Changes for Study: NCT04979000
HPV in Sinonasal Ca: Retrospective Analysis Association of Human Papilloma Virus (HPV) Serology and Behavioral Risk Factors
Latest version (submitted August 30, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 23, 2021 None (earliest Version on record)
2 July 28, 2022 Study Status
3 August 30, 2023 Study Status
Comparison Format:
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Study NCT04979000
Submitted Date:  July 23, 2021 (v1)
Open or close this module Study Identification
Unique Protocol ID: J20108
Brief Title: HPV in Sinonasal Ca: Retrospective Analysis Association of Human Papilloma Virus (HPV) Serology and Behavioral Risk Factors
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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2021
Overall Status: Recruiting
Study Start: January 30, 2021
Primary Completion: January 30, 2026 [Anticipated]
Study Completion: January 30, 2028 [Anticipated]
First Submitted: July 9, 2021
First Submitted that
Met QC Criteria:		 July 23, 2021
First Posted: July 27, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:		 July 23, 2021
Last Update Posted: July 27, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Responsible Party: Sponsor
Collaborators: Merck Sharp & Dohme LLC
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Sinonasal Carcinoma
HPV-Related Squamous Cell Carcinoma
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Control
Time Perspective: Retrospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: For cases, paraffin embedded tumor samples will be tested for HPV. The blood sample collected at baseline (both cases and controls) will be tested for HPV antibodies.
Enrollment: 499 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Cases
Patients with a confirmed diagnosis of sinonasal cancer.
Controls
Patients being seen for benign conditions at Johns Hopkins.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. HPV Status
[ Time Frame: Collected at time of surgery or previously conducted biopsy ]

High risk HPV present or absent in tumor
Secondary Outcome Measures:
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).
Open or close this module Eligibility
Study Population:

Cases:

Patients with a confirmed diagnosis of sinonasal cancer, or clinical findings consistent with this diagnosis, seen in the Departments of Otolaryngology/Head and Neck Surgery, Radiation Oncology, or Medical Oncology of the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (SKCCC) or Johns Hopkins Head and Neck Surgery at Suburban Hospital are eligible for this study.

Controls:

Patients seen for benign conditions in the same Departments of Otolaryngology/Head and Neck Surgery, Radiation Oncology, and Medical Oncology at SKCCC or Suburban Hospital are eligible for enrollment as non-cancer controls in this study.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Central Contact Person: Nyall London, M.D.
Telephone: 301-896-3332
Email: nlondon2@jhmi.edu
Central Contact Backup: Zubair Khan, M.D.
Telephone: 410-955-3157
Email: zkhan@jhmi.edu
Study Officials: Nyall London, M.D.
Principal Investigator
Department of Otolaryngology and Surgery
Locations: United States, Maryland
Johns Hopkins University
[Recruiting]
Baltimore, Maryland, United States, 21287
Contact:Contact: Nyall London, M.D. 301-896-3332 nlondon2@jhmi.edu
Contact:Contact: Zubair Khan, M.D. 410-955-3157 zkhan@jhmi.edu
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:
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