Clinical trial NCT04979000: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sinonasal Carcinoma
HPV-Related Squamous Cell Carcinoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-07-27
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


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

Primary outcomes:
measure: HPV Status
timeFrame: Collected at time of surgery or previously conducted biopsy
Secondary outcomes:
measure: Gender Differences
timeFrame: completion of the study, approximately 2 years
measure: Race/Ethnicity Differences
timeFrame: completion of the study, approximately 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Department of Otolaryngology and Surgery
name: Nyall London, M.D.
role: PRINCIPAL_INVESTIGATOR
References: