Clinical trial · Observational
Men and Women Offering Understanding of Throat HPV
Impacting the Oral HPV Continuum: MOUTH Study (Men and Women Offering Understanding of Throat HPV)
NCT03644563CI-TRIAL-00094949MOUTHactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
This study will screen people for oncogenic oral Human Papillomavirus (HPV) infection and antibodies to form a cohort of people who may be at increased risk of HPV-oropharyngeal cancer (HPV-OPC). The investigators will follow these individuals prospectively to evaluate oncogenic oral HPV persistence, risk factors, and biomarkers for persistence.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papilloma Virus | — | UNRESOLVED | — |
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Follow-up
- description
- Those subjects with oncogenic oral HPV infection and/or HPV oncogene serum antibodies from screening.
Primary outcomes (1)
- measure
- Oncogenic oral HPV infection present or absent in oral rinse sample
- timeFrame
- Baseline to end of four year follow-up and data abstraction/linkage.
- description
- To explore the effects of biologic (microbiome, oral immune response, biologic sex) risk factors for oncogenic oral HPV persistence
Secondary outcomes (1)
- measure
- HPV16 E6 antibodies present or absent in serum sample
- timeFrame
- Baseline to end of four year follow-up and data abstraction/linkage.
- description
- To explore whether E6 and E7 seropositivity (to HPV16 or any oncogenic HPV) are markers for oncogenic oral HPV persistence among high-risk groups
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Participants in the Phase 1 Screening Inclusion criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * 18 and older (enrollment at most sites will be restricted to 30 and older since this demographic has the highest prevalence of infection; however, individuals and/or partners of someone with an HPV-related cancer, for example, are at increased risk so will be enrolled in the larger age range). * Willing to be contacted to arrange follow-up visits, if determined to be eligible for phase 2 * Ability to understand and the willingness to sign a written informed consent document In addition, individuals must meet at least one of the following criteria: * Male, aged 30 and older, with 2 or more lifetime oral sex * History of anal or genital dysplasia or cancer * Partners of someone with an HPV-related cancer (HPV-positive OPC, anal cancer or genital cancer) * Known oncogenic HPV-positive biomarker from prior studies or testing, regardless of number of partners. Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent. * Participants who do not speak English cannot enroll because the consent and study survey are only available in English. 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. * History of head and neck cancer Participants in the Phase 2 Follow-Up Inclusion criteria: * Oncogenic oral HPV infection and/or HPV serum oncogenic antibodies detected in phase 1 * Willingness to complete annual follow up visits Exclusion criteria: • Unable to complete annual follow up visits
References
Publications (3)
- RESULTD'Souza G, Clemens G, Troy T, Castillo RG, Struijk L, Waterboer T, Bender N, Pierorazio PM, Best SR, Strickler H, Wiley DJ, Haddad RI, Posner M, Fakhry C. Evaluating the Utility and Prevalence of HPV Biomarkers in Oral Rinses and Serology for HPV-related Oropharyngeal Cancer. Cancer Prev Res (Phila). 2019 Oct;12(10):689-700. doi: 10.1158/1940-6207.CAPR-19-0185. Epub 2019 Aug 16. PMID 31420362
- RESULTD'Souza G, Tewari SR, Troy T, Waterboer T, Struijk L, Castillo R, Wright H, Shen M, Miles B, Johansson M, Robbins HA, Fakhry C. Prevalence of oral and blood oncogenic human papillomavirus biomarkers among an enriched screening population: Baseline results of the MOUTH study. Cancer. 2023 Aug 1;129(15):2373-2384. doi: 10.1002/cncr.34783. Epub 2023 Apr 9. PMID 37032449
- RESULTD'Souza G, Tewari SR, Troy T, Webster-Cyriaque J, Wiley DJ, Lahiri CD, Palella FJ, Gillison ML, Strickler HD, Struijk L, Waterboer T, Ho K, Kwait J, Lazar J, Weber KM, Fakhry C. Oncogenic Oral Human Papillomavirus Clearance Patterns over 10 Years. Cancer Epidemiol Biomarkers Prev. 2024 Apr 3;33(4):516-524. doi: 10.1158/1055-9965.EPI-23-1272. PMID 38294704