This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 5 for:    sinonasal HPV
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04979000
Recruitment Status : Recruiting
First Posted : July 27, 2021
Last Update Posted : September 5, 2023
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Sinonasal Carcinoma HPV-Related Squamous Cell Carcinoma

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 499 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : August 3, 2021
Estimated Primary Completion Date : January 30, 2026
Estimated Study Completion Date : January 30, 2028
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Cases
Patients with a confirmed diagnosis of sinonasal cancer.
Controls
Patients being seen for benign conditions at Johns Hopkins.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).


Biospecimen Retention:   Samples With DNA
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.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04979000


Contacts
Layout table for location contacts
Contact: Nyall London, M.D. 301-896-3332 nlondon2@jhmi.edu
Contact: Zubair Khan, M.D. 410-955-3157 zkhan@jhmi.edu

Locations
Layout table for location information
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Nyall London, M.D.    301-896-3332    nlondon2@jhmi.edu   
Contact: Zubair Khan, M.D.    410-955-3157    zkhan@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Merck Sharp & Dohme LLC
Investigators
Layout table for investigator information
Principal Investigator: Nyall London, M.D. Department of Otolaryngology and Surgery
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT04979000    
Other Study ID Numbers: J20108
First Posted: July 27, 2021    Key Record Dates
Last Update Posted: September 5, 2023
Last Verified: August 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms