NCT03644563

Brief 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). The investigators will follow these individuals prospectively to evaluate oncogenic oral HPV persistence, risk factors, and biomarkers for persistence.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Apr 2017Jun 2028

Study Start

First participant enrolled

April 3, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2026

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Expected
Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

9.4 years

First QC Date

August 21, 2018

Last Update Submit

September 24, 2026

Conditions

Oropharyngeal CancerHuman Papilloma Virus

Keywords

Oral HPVPersistent infectionOropharyngeal cancer (OPC)HPV antibodyHPV Screening Study

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline to end of four year follow-up and data abstraction/linkage.

Secondary Outcomes (1)

  • HPV16 E6 antibodies present or absent in serum sample

    Baseline to end of four year follow-up and data abstraction/linkage.

Study Arms (1)

Follow-up

Those subjects with oncogenic oral HPV infection and/or HPV oncogene serum antibodies from screening.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • 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.

You may not qualify if:

  • 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
  • Oncogenic oral HPV infection and/or HPV serum oncogenic antibodies detected in phase 1
  • Willingness to complete annual follow up visits
  • Unable to complete annual follow up visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

  • 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.

    PMID: 31420362RESULT

  • D'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: 37032449RESULT

  • D'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: 38294704RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Oral rinse sample: a sample of oral exfoliated cells will be collected using 10 mL of saline.Oral rinse samples will be tested for HPV DNA and/or RNA. Saliva sample: Saliva sampling kits designed to preserve HPV (OraGene RNA kit from DNA Genotek) will be used to collect oral samples from all participants. Urine sample: Urine will be tested for HPV DNA as a surrogate for genital HPV infection. Blood collection: Each sample will be tested for HPV antibodies. Capsid antibodies will be measured using virus like particle-based ELISA assays. Antibodies to the E6 and E7 proteins will be measured in a glutathione capture ELISA assays.

MeSH Terms

Conditions

Oropharyngeal NeoplasmsPersistent Infection

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amber D'Souza, PhD

    Bloomberg Johns Hopkins School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 23, 2018

Study Start

April 3, 2017

Primary Completion

August 12, 2026

Study Completion (Estimated)

June 1, 2028

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)