Sinonasal CarcinomaNCT04979000
HPV in Sinonasal Ca: Retrospective Analysis Association of Human Papilloma Virus (HPV) Serology and Behavioral Risk Factors
An observational study of Sinonasal Carcinoma and HPV-Related Squamous Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sinonasal Carcinoma, HPV-Related Squamous Cell Carcinoma
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2021to 28 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with a confirmed diagnosis of sinonasal cancer. | |
| Controls | Patients being seen for benign conditions at Johns Hopkins. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV Status
High risk HPV present or absent in tumor
Measured: Collected at time of surgery or previously conducted biopsy
Secondary outcomes (2)
Gender Differences
Gender differences in HPV-HNSCC risk factors (tobacco, alcohol, drug use and sexual behavior).
Measured: completion of the study, approximately 2 years
Race/Ethnicity Differences
Race/ethnicity differences in HPV-HNSCC risk factors (tobacco, alcohol, drug use and sexual behavior).
Measured: completion of the study, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start3 Aug 2021
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinonasal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Nyall London, M.D., Principal investigator, Department of Otolaryngology and Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979000
- Sponsor's protocol ID
- J20108
- Other IDs
- IRB00270617
- Status last verified
- Sep 2025
- First submitted
- 9 Jul 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04979000
- Acronym / sponsor ID
- J20108
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Patients with a confirmed diagnosis of sinonasal cancer. |
| Controls | – | –Patients being seen for benign conditions at Johns Hopkins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Cases:
- Controls:
Key exclusion criteria (8 listed)
- Cases:
- Controls:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HPV Status
Time frame: Collected at time of surgery or previously conducted biopsy
High risk HPV present or absent in tumor
2 secondary outcomes
Gender Differences
Time frame: completion of the study, approximately 2 years
Race/Ethnicity Differences
Time frame: completion of the study, approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nyall London, M.D. principal investigator
Department of Otolaryngology and Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinonasal Carcinoma and HPV-Related Squamous Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV Status (time frame: Collected at time of surgery or previously conducted biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.