The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 6 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

Tracking Information
First Submitted Date July 9, 2021
First Posted Date July 27, 2021
Last Update Posted Date September 5, 2023
Actual Study Start Date August 3, 2021
Estimated Primary Completion Date January 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2021)		 HPV Status [ Time Frame: Collected at time of surgery or previously conducted biopsy ]
High risk HPV present or absent in tumor
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 23, 2021)
  • 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).
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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 Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
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.
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.
Condition
  • Sinonasal Carcinoma
  • HPV-Related Squamous Cell Carcinoma
Intervention Not Provided
Study Groups/Cohorts
  • Cases
    Patients with a confirmed diagnosis of sinonasal cancer.
  • Controls
    Patients being seen for benign conditions at Johns Hopkins.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 23, 2021)		 499
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 30, 2028
Estimated Primary Completion Date January 30, 2026   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Nyall London, M.D. 301-896-3332 nlondon2@jhmi.edu
Contact: Zubair Khan, M.D. 410-955-3157 zkhan@jhmi.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04979000
Other Study ID Numbers J20108
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Original Responsible Party Same as current
Current Study Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Original Study Sponsor Same as current
Collaborators Merck Sharp & Dohme LLC
Investigators
Principal Investigator: Nyall London, M.D. Department of Otolaryngology and Surgery
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date August 2023