NCT00711815

Brief Summary

This is a research study looking at gene characteristics in blood and Pap smear samples in hopes of identifying markers that will predict if the HPV infection is present or not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

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

January 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

August 5, 2011

Status Verified

August 1, 2011

Enrollment Period

3.8 years

First QC Date

July 3, 2008

Last Update Submit

August 4, 2011

Conditions

HPV Infections

Keywords

Women of the state of AlabamaCIN 1negative biopsynormal colposcopyHPV

Study Arms (1)

UA

HPV positive

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HPV-positive women with biopsy-confirmed CIN 1 or negative biopsies or normal colposcopic findings

You may qualify if:

  • HPV positive

You may not qualify if:

  • Negative for HPV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, cervical cells

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Warner K Huh, M.D.

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 9, 2008

Study Start

January 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

August 5, 2011

Record last verified: 2011-08

Locations

US(1)