NCT00994019

Brief Summary

Recently human papillomavirus (HPV) has been recognized to cause some oropharyngeal (tonsil) cancer. But very little is known about oral HPV infection and risk factors. This study will evaluate how common oral HPV infection is, what sexual behaviors are associated with risk for infection, and how long infections tend to last.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

4.8 years

First QC Date

October 13, 2009

Last Update Submit

January 6, 2020

Conditions

STD

Keywords

HPVoral canceryoung adults

Outcome Measures

Primary Outcomes (1)

  • Oral HPV infection

    Oral rinse samples collected prospectively for 24 months

    24 months

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

High risk young adults

You may qualify if:

  • Age 18 -26 years

You may not qualify if:

  • Never received HPV vaccine (Gardasil or Cervarix)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baltimore County Woodlawn Health Centers

Baltimore, Maryland, 21207, United States

Location

Baltimore County Eastern Health Center

Baltimore, Maryland, 21237, United States

Location

Related Publications (2)

  • D'Souza G, Wentz A, Kluz N, Zhang Y, Sugar E, Youngfellow RM, Guo Y, Xiao W, Gillison ML. Sex Differences in Risk Factors and Natural History of Oral Human Papillomavirus Infection. J Infect Dis. 2016 Jun 15;213(12):1893-6. doi: 10.1093/infdis/jiw063. Epub 2016 Feb 10.

    PMID: 26908748RESULT

  • D'Souza G, Kluz N, Wentz A, Youngfellow RM, Griffioen A, Stammer E, Guo Y, Xiao W, Gillison ML. Oral Human Papillomavirus (HPV) Infection among Unvaccinated High-Risk Young Adults. Cancers (Basel). 2014 Aug 14;6(3):1691-704. doi: 10.3390/cancers6031691.

    PMID: 25256827RESULT

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Gypsyamber D'Souza, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

January 1, 2010

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 9, 2020

Record last verified: 2020-01

Locations

US(2)