Clinical trial · Interventional
New Modalities for Detection of Oropharyngeal Cancer
Advancing New Modalities for the Detection of Oropharyngeal Cancer: Transcervical Ultrasound and HPV16 E6 Antibodies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: The incidence of human papilloma virus-driven oropharyngeal cancer (HPV-OPC), a type of head and neck cancer, is rapidly increasing within the US. Currently, there are no screening methods for early detection. HPV16 E6 antibodies combined with ultrasound imaging may be a promising method for early detection of HPV-OPC. However, prior to testing HPV16 E6 antibodies and ultrasound for HPV-OPC screening, larger studies are needed to further validate the utility of these methods in the diagnostic setting among patients with suspected and/or symptomatic HPV-OPC. Objective/Hypothesis: To investigate two promising screening modalities for the detection of HPV-OPC, transcervical ultrasound and HPV16 E6 antibodies. The investigators hypothesize that both ultrasound and HPV16 E6 antibodies will be highly sensitive for the detection of symptomatic HPV-OPC. Specific Aims: (1) Determine the sensitivity of ultrasound to characterize OPC tumors compared to current standard imaging modalities among patients with suspected or confirmed OPC. (2) To determine the sensitivity and specificity of HPV16 E6 antibodies for HPV-OPC. (3) Determine the sensitivity of ultrasound to detect HPV-OPC compared to current standard imaging modalities among patients that present with a neck mass and unknown primary tumor.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Base of Tongue Carcinoma | Posterior Tongue Carcinoma | ALIAS | 0.90 |
| Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma | Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
| Tonsil Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Draw | Procedure | — | UNRESOLVED |
| Oral Rinse Collection | Procedure | — | UNRESOLVED |
| Transcervical Oropharyngeal Ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with suspected or known oropharyngeal cancer
- description
- Patients with either known or suspected oropharyngeal cancer will be asked to undergo a transcervical ultrasound and to provide a blood and oral rinse specimen.
- interventionNames
- Procedure: Transcervical Oropharyngeal Ultrasound
- Procedure: Oral Rinse Collection
- Procedure: Blood Draw
Primary outcomes (1)
- measure
- Detection of tumor via transcervical ultrasound
- timeFrame
- 1 day at time of clinic visit
- description
- Ability to detect oropharyngeal tumor via ultrasound will be a primary outcome of the study. Characteristics including ability to detect tumor, tumor size, and tumor location will be recorded at time of ultrasound. The ultrasound findings will then be compared to other imaging modalities used as standard work-up (CT/MRI). This comparison will be used to determine sensitivity of ultrasound for detection of oropharyngeal tumors.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 21 years or older * Suspected or confirmed oropharyngeal cancer * Previously untreated cancer * First cancer diagnosis Exclusion Criteria: * No to any of the inclusion criteria * Under 21 years of age * Inability to provide blood or oral rinse specimen
References
Publications (6)
- BACKGROUNDChaturvedi AK, Engels EA, Pfeiffer RM, Hernandez BY, Xiao W, Kim E, Jiang B, Goodman MT, Sibug-Saber M, Cozen W, Liu L, Lynch CF, Wentzensen N, Jordan RC, Altekruse S, Anderson WF, Rosenberg PS, Gillison ML. Human papillomavirus and rising oropharyngeal cancer incidence in the United States. J Clin Oncol. 2011 Nov 10;29(32):4294-301. doi: 10.1200/JCO.2011.36.4596. Epub 2011 Oct 3. PMID 21969503
- BACKGROUNDCoquia SF, Hamper UM, Holman ME, DeJong MR, Subramaniam RM, Aygun N, Fakhry C. Visualization of the Oropharynx With Transcervical Ultrasound. AJR Am J Roentgenol. 2015 Dec;205(6):1288-94. doi: 10.2214/AJR.15.14299. PMID 26587936
- BACKGROUNDFakhry C, Agrawal N, Califano J, Messing B, Liu J, Saunders J, Ha P, Coquia S, Hamper U, Gillison M, Blanco R. The use of ultrasound in the search for the primary site of unknown primary head and neck squamous cell cancers. Oral Oncol. 2014 Jul;50(7):640-5. doi: 10.1016/j.oraloncology.2014.03.015. Epub 2014 May 10. PMID 24819862
- BACKGROUNDKreimer AR, Johansson M, Yanik EL, Katki HA, Check DP, Lang Kuhs KA, Willhauck-Fleckenstein M, Holzinger D, Hildesheim A, Pfeiffer R, Williams C, Freedman ND, Huang WY, Purdue MP, Michel A, Pawlita M, Brennan P, Waterboer T. Kinetics of the Human Papillomavirus Type 16 E6 Antibody Response Prior to Oropharyngeal Cancer. J Natl Cancer Inst. 2017 Aug 1;109(8):djx005. doi: 10.1093/jnci/djx005. PMID 28376197
- BACKGROUNDHolzinger D, Wichmann G, Baboci L, Michel A, Hofler D, Wiesenfarth M, Schroeder L, Boscolo-Rizzo P, Herold-Mende C, Dyckhoff G, Boehm A, Del Mistro A, Bosch FX, Dietz A, Pawlita M, Waterboer T. Sensitivity and specificity of antibodies against HPV16 E6 and other early proteins for the detection of HPV16-driven oropharyngeal squamous cell carcinoma. Int J Cancer. 2017 Jun 15;140(12):2748-2757. doi: 10.1002/ijc.30697. Epub 2017 Apr 4. PMID 28316084
- BACKGROUNDLang Kuhs KA, Pawlita M, Gibson SP, Schmitt NC, Trivedi S, Argiris A, Kreimer AR, Ferris RL, Waterboer T. Characterization of human papillomavirus antibodies in individuals with head and neck cancer. Cancer Epidemiol. 2016 Jun;42:46-52. doi: 10.1016/j.canep.2016.03.003. Epub 2016 Mar 21.