Oropharyngeal CancerMOUTHNCT03644563
Men and Women Offering Understanding of Throat HPV
An observational study of Oropharyngeal Cancer and Human Papilloma Virus, run by Johns Hopkins University at 1 site in United States.
Trial summary
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). 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, Human Papilloma Virus
- Type of treatment
- Pill or oral medicine
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2017to Jun 2028
- How long will I take part?
- 4 Years
- 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: Target sample size: 1325 (phase 1), ~250 (phase 2) Inclusion of women and minorities: Primary enrollment is restricted to men, given their higher risk of infection (see eligibility criteria). However, the investigators expect to enroll women with cervical dysplasia and partners of patients with HPV-related cancer (~125 expected women enrollees). Enrollment is across many different sources (geographically, and by clinic type), and is inclusive of diverse racial and ethnic backgrounds. Enrollment is not stratified by race but the investigators expect to enroll at least 175 minorities in the study.
Who may be able to join
- 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
Show all 11Show fewer
- 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.
- Oncogenic oral HPV infection and/or HPV serum oncogenic antibodies detected in phase 1
- Willingness to complete annual follow up visits
Who cannot join
- 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
- Unable to complete annual follow up visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impacting the Oral HPV Continuum: MOUTH Study (Men and Women Offering Understanding of Throat HPV)
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.
Read the detailed description
This study will provide one of the first estimates of long-term oral HPV natural history, and the effect of biologic and behavioral risk factors, including HIV, on this natural history. Phase 1 of the study will screen approximately 1500 people for oncogenic oral HPV biomarkers. Phase 2 of the study will follow only those subjects with oncogenic oral HPV infection and/or HPV serum oncogene antibodies from Phase 1 (and those previously identified as having oncogenic oral HPV infection in a previous study) with annual follow-up for oncogenic oral HPV persistence.
Understanding persistent oncogenic oral HPV infection is the focus of this study. Understanding which factors drive oral HPV infection to become persistent or progress to malignancy is critical to determine who is at high risk for oropharyngeal cancer and may benefit from screening and prevention. It is presumed that persistent oncogenic oral HPV infections are necessary for progression to HPV-OPC.
The study is led by Dr. Amber D'Souza and Dr Carole Fakhry (Johns Hopkins) and participants are being enrolled in Baltimore MD (Johns Hopkins) and in New York (Mt. Sinai).
- Conditions
- Oropharyngeal Cancer, Human Papilloma Virus
- Keywords
- Oral HPV, Persistent infection, Oropharyngeal cancer (OPC), HPV antibody, HPV Screening Study
- Medical subject headings
- Oropharyngeal Neoplasms, Persistent Infection
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 |
|---|---|---|
| Follow-up | Those subjects with oncogenic oral HPV infection and/or HPV oncogene serum antibodies from screening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncogenic oral HPV infection present or absent in oral rinse sample
To explore the effects of biologic (microbiome, oral immune response, biologic sex) risk factors for oncogenic oral HPV persistence
Measured: Baseline to end of four year follow-up and data abstraction/linkage.
Secondary outcomes (1)
HPV16 E6 antibodies present or absent in serum sample
To explore whether E6 and E7 seropositivity (to HPV16 or any oncogenic HPV) are markers for oncogenic oral HPV persistence among high-risk groups
Measured: Baseline to end of four year follow-up and data abstraction/linkage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start3 Apr 2017
- Primary completion12 Aug 2026
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Amber D'Souza, PhD, Principal investigator, Bloomberg Johns Hopkins School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644563
- Sponsor's protocol ID
- IRB00119537
- Other IDs
- R35DE026631
- Acronym
- MOUTH
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2018
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'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.
PubMed 31420362D'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.
PubMed 37032449D'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.
PubMed 38294704
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacting the Oral HPV Continuum: MOUTH Study (Men and Women Offering Understanding of Throat HPV)
- ClinicalTrials.gov ID
- NCT03644563
- Acronym / sponsor ID
- MOUTH / IRB00119537
- Conditions
- Oropharyngeal Cancer, Human Papilloma Virus
- Keywords
- Oral HPV, Persistent infection, Oropharyngeal cancer (OPC), HPV antibody, HPV Screening Study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- Jun 2028 (estimated)
- First posted
- 23 Aug 2018 (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 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.
Detailed description
This study will provide one of the first estimates of long-term oral HPV natural history, and the effect of biologic and behavioral risk factors, including HIV, on this natural history. Phase 1 of the study will screen approximately 1500 people for oncogenic oral HPV biomarkers. Phase 2 of the study will follow only those subjects with oncogenic oral HPV infection and/or HPV serum oncogene antibodies from Phase 1 (and those previously identified as having oncogenic oral HPV infection in a previous study) with annual follow-up for oncogenic oral HPV persistence.
Understanding persistent oncogenic oral HPV infection is the focus of this study. Understanding which factors drive oral HPV infection to become persistent or progress to malignancy is critical to determine who is at high risk for oropharyngeal cancer and may benefit from screening and prevention. It is presumed that persistent oncogenic oral HPV infections are necessary for progression to HPV-OPC.
The study is led by Dr. Amber D'Souza and Dr Carole Fakhry (Johns Hopkins) and participants are being enrolled in Baltimore MD (Johns Hopkins) and in New York (Mt. Sinai).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up | – | –Those subjects with oncogenic oral HPV infection and/or HPV oncogene serum antibodies from screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Target sample size: 1325 (phase 1), ~250 (phase 2) Inclusion of women and minorities: Primary enrollment is restricted to men, given their higher risk of infection (see eligibility criteria). However, the investigators expect to enroll women with cervical dysplasia and partners of patients with HPV-related cancer (~125 expected women enrollees). Enrollment is across many different sources (geographically, and by clinic type), and is inclusive of diverse racial and ethnic backgrounds. Enrollment is not stratified by race but the investigators expect to enroll at least 175 minorities in the study.
Key inclusion criteria (11 listed)
- 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
- Male, aged 30 and older, with 2 or more lifetime oral sex
Key exclusion criteria (6 listed)
- 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
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
Oncogenic oral HPV infection present or absent in oral rinse sample
Time frame: Baseline to end of four year follow-up and data abstraction/linkage.
To explore the effects of biologic (microbiome, oral immune response, biologic sex) risk factors for oncogenic oral HPV persistence
1 secondary outcome
HPV16 E6 antibodies present or absent in serum sample
Time frame: Baseline to end of four year follow-up and data abstraction/linkage.
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 28 Sep 2026.
- Results publication: PubMed 31420362D'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.
- Results publication: PubMed 37032449D'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.
- Results publication: PubMed 38294704D'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.
- MOUTH Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Amber D'Souza, PhD principal investigator
Bloomberg Johns Hopkins School of Public Health
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 Oropharyngeal Cancer and Human Papilloma Virus, run by Johns Hopkins University 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 11 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 28 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 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?
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?
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?
Oncogenic oral HPV infection present or absent in oral rinse sample (time frame: Baseline to end of four year follow-up and data abstraction/linkage.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644563, which also lists 3 linked publications.
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 28 Sep 2026.