HPV in Sinonasal Ca: Retrospective Analysis Association of Human Papilloma Virus (HPV) Serology a… (NCT04979000) | Clinical Trial Compass
CompletedNot Applicable
HPV in Sinonasal Ca: Retrospective Analysis Association of Human Papilloma Virus (HPV) Serology and Behavioral Risk Factors
United States49 participantsStarted 2021-08-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 e…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HPV Status
Timeframe: Collected at time of surgery or previously conducted biopsy
Trial details
NCT IDNCT04979000
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins