An observational study in Oropharyngeal Cancer and HPV-Related Carcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 233 studies in Oropharyngeal Neoplasms with a site in United States — 61 open to participants now, 96 under way, 10 of them phase 3. Oropharyngeal Neoplasms · United States.
Among the 233 studies in Oropharyngeal Neoplasms with a site in United States, this one is the 14th largest by planned enrollment of the 35 observational ones that give a count, is one of 11 that started in 2024, is one of 35 observational ones, reaches primary completion later than 70 of the 95 other live ones, and was the 205th registered.
369 studies on the registry are indexed under Oropharyngeal Neoplasms; 103 are open to participants now.
Browse Oropharyngeal Neoplasms studies →61 of the 233 studies in Oropharyngeal Neoplasms with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
University of Maryland, Baltimore · Sites in United States
Ages 18+
Metaclipse Therapeutics Corporation · Sites in United States
Ages 18+
Corbus Pharmaceuticals Inc. · Sites in United States, Austria, Belgium and 11 more countries
Ages 18+
OHSU Knight Cancer Institute · Sites in United States
Ages 18–89
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 89 Oropharyngeal Neoplasms studies recruiting now, 76 (85%) set no upper age limit and 5 (6%) stop at 75 or younger; none take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
233 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 45 · Phase 2 108 · Phase 3 20 · Phase 4 3
First in 1995; this study’s year is marked. 11 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 400 is above the median of 137 across 74 observational studies indexed under Oropharyngeal Neoplasms.
Median enrollment 42 across the 188 interventional studies, 185 across the 35 observational. Of the 120 that completed or were terminated, 53 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 233 have an industry lead sponsor. The 10 most frequent:
H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 540 studies on the registry; 75 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
H. Lee Moffitt Cancer Center and Research Institute has 3 studies filed under Oropharyngeal Neoplasms — fewer than ten, so there is no comparison to draw.
32 of the studies in Oropharyngeal Neoplasms with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01266044Phase 3M.D. Anderson Cancer CenterControlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia | 2026-12-31 |
| NCT05050162Phase 3NRG OncologyComparing Cisplatin Every Three Weeks to Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer | 2027-02-09 |
| NCT02215265Phase 3Lisette NixonPost-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS) | 2027-10 |
| NCT04609280University of Maryland, BaltimoreSelective Avoidance of Nodal VolumEs at Minimal Risk (GCC 20110) | 2026-12 |
| NCT05312710Aveta Biomics, Inc.Safety and Efficacy of APG-157 in Head and Neck Cancer | 2026-12 |
Add all 32 to your calendar (.ics) → With an account.
Among the 233 studies in Oropharyngeal Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cases:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Case group will consist of early and late disease pre-treatment Oropharyngeal Cancer cases.
Diagnostic Test: combined HPV 16 DNA and host gene methylation oral biomarker panel
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.
Diagnostic Test: combined HPV 16 DNA and host gene methylation oral biomarker panel
DNA Methylation Profiling
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.
Time frame: 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.
Time frame: Up to 60 months
Started Jan 2024 (actual). Primary completion is estimated for Jan 2029, 60 months after the start.
Of 47 observational studies under Oropharyngeal Neoplasms, half reached primary completion within 110 months of starting (the median), counting those still running; a quarter within 40. This study's planned 60 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
H. Lee Moffitt Cancer Center and Research Institute →