NCT01295242

Brief Summary

The purpose of this study is to determine rates of oral and genital human papillomavirus (HPV) infections, and look at risk factors for HPV infection in healthy mid-adult women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
409

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

1.5 years

First QC Date

February 2, 2011

Last Update Submit

November 15, 2013

Conditions

Papillomavirus Infections

Keywords

HPVCervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Presence of type-specific HPV DNA in self-collected oral and vaginal swab samples

    once a month for 6 months

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

30 to 50 year old women affilitated with Univeristy of Washington (student, staff, faculty)

You may qualify if:

  • affiliated with the University of Washington (student, staff, faculty)
  • willing to self-collect vaginal samples at home for HPV testing
  • able to provide informed consent

You may not qualify if:

  • pregnant
  • have had hysterectomy
  • serious medical condition which prevents completion of activities of daily living

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Self-collected vaginal samples for HPV testing. Self-collected oral samples for HPV testing. Serum samples for HPV antibody testing.

MeSH Terms

Conditions

Papillomavirus InfectionsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Rachel L Winer, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 2, 2011

First Posted

February 14, 2011

Study Start

February 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

US(1)