Oropharyngeal CancerBASH OPCNCT06305676
Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
An observational study of Oropharyngeal Cancer and HPV-Related Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in United States.
Trial summary
Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oropharyngeal Cancer, HPV-Related Carcinoma
- What is being tested?
- combined HPV 16 DNA and host gene methylation oral biomarker panel
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jan 2024to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population will consist of 100 early and 100 late disease pre-treatment Oropharyngeal Cancer cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).
Who may be able to join
- Cases:
- Aged at least 18 years
- Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV)
- Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks
- Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center
- Aged at least 35 years
Show all 9Show fewer
- Have no previous diagnosis of HNC or HPV-related cancer
- Fully understands study procedures
- Voluntarily agrees to participate by giving written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center
Who cannot join
- Not meeting all of the above inclusion criteria for either the case or control group
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Jose P. Zevallos, MD, PhD, zevallosjp@upmc.edu
Robert Ferris, PhD, ferrrl@UPMC.EDU
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Kimberly Isaacs-Soriano, 813-745-6992, kimberly.Isaacs-Soriano@moffitt.org
Anna Giuliano, PhD
About this study
Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).
- Conditions
- Oropharyngeal Cancer, HPV-Related Carcinoma
- Being tested
- combined HPV 16 DNA and host gene methylation oral biomarker panel
- Keywords
- Oropharyngeal Cancer, Early Detection, Screening
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined HPV 16 DNA and host gene methylation oral biomarker panelDiagnostic test
DNA Methylation Profiling
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Case group will consist of early and late disease pre-treatment Oropharyngeal Cancer cases. Receives: Diagnostic Test: combined HPV 16 DNA and host gene methylation oral biomarker panel | |
| Control Group | Controls will be enrolled from members of the catchment area to ensure geographic comparability of cases and controls. Controls will be matched by sex, age, race/ethnicity, and tobacco use. Receives: Diagnostic Test: combined HPV 16 DNA and host gene methylation oral biomarker panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Sensitivity
A 95% one-sided confidence interval using the Wilson method will be obtained for sensitivity for the early Oropharyngeal Cancer cases and late Oropharyngeal Cancer cases.
Measured: Up to 60 months
Diagnostic Specificity
A 95% one-sided confidence interval using the Wilson method will be obtained for Specificity based on the control patients.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start22 Jan 2024
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Anna Giuliano, PhD, Principal investigator, Moffitt Cancer CenterAntonio Amelio, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305676
- Sponsor's protocol ID
- MCC-23073
- Acronym
- BASH OPC
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
- ClinicalTrials.gov ID
- NCT06305676
- Acronym / sponsor ID
- BASH OPC / MCC-23073
- Conditions
- Oropharyngeal Cancer, HPV-Related Carcinoma
- Keywords
- Oropharyngeal Cancer, Early Detection, Screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 12 Mar 2024 (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.
Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Diagnostic Test: combined HPV 16 DNA and host gene methylation oral biomarker panelCase group will consist of early and late disease pre-treatment Oropharyngeal Cancer cases. |
| Control Group | – | Diagnostic Test: combined HPV 16 DNA and host gene methylation oral biomarker panelControls will be enrolled from members of the catchment area to ensure geographic comparability of cases and controls. Controls will be matched by sex, age, race/ethnicity, and tobacco use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 100 early and 100 late disease pre-treatment Oropharyngeal Cancer cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).
Key inclusion criteria (9 listed)
- Aged at least 18 years
- Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV)
- Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks
- Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center
- Aged at least 35 years
Key exclusion criteria (1 listed)
- Not meeting all of the above inclusion criteria for either the case or control group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined HPV 16 DNA and host gene methylation oral biomarker panelDNA Methylation Profiling | Diagnostic test | Case Group, Control Group |
Primary outcome
Diagnostic Sensitivity
Time frame: Up to 60 months
A 95% one-sided confidence interval using the Wilson method will be obtained for sensitivity for the early Oropharyngeal Cancer cases and late Oropharyngeal Cancer cases.
Diagnostic Specificity
Time frame: Up to 60 months
A 95% one-sided confidence interval using the Wilson method will be obtained for Specificity based on the control patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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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.
Anna Giuliano, PhD principal investigator
Moffitt Cancer Center
Antonio Amelio, PhD principal investigator
Moffitt Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Cancer and HPV-Related Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites 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 9 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Isaacs-Soriano (813-745-6992, kimberly.Isaacs-Soriano@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Sensitivity (time frame: Up to 60 months). The study lists 2 primary outcomes in all. 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 23 Sep 2026.