NCT01265212

Brief Summary

HPV infection is associated with cervical and other anogenital cancers. HPV may also be associated with the development of prostate cancer. The purpose of the study is to determine the prevalence of HPV infection in men living in South Dakota.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2010

Typical duration 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

September 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

3 years

First QC Date

December 22, 2010

Last Update Submit

June 28, 2017

Conditions

Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (1)

  • Determine the prevalence of HPV in men living on the Northern Plains

    No time point

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male residents of South Dakota.

You may qualify if:

  • Male
  • Ages 18-65
  • Living in South Dakota (AKA Northern Plains)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Epithelial skin swabs collected for the purpose of HPV DNA detection. DNA extraction and HPV testing will be performed.

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

  • Diane Maher, PhD

    Sanford Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2010

First Posted

December 23, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

US(1)