Prevalence of Human Papillomavirus in Men Living in the Northern Plains

This study is currently recruiting participants.
Verified September 2013 by Sanford Health
Sponsor:
Information provided by (Responsible Party):
Diane Maher, Sanford Health
ClinicalTrials.gov Identifier:
NCT01265212
First received: December 22, 2010
Last updated: September 4, 2013
Last verified: September 2013

December 22, 2010
September 4, 2013
September 2010
September 2013   (final data collection date for primary outcome measure)
Determine the prevalence of HPV in men living on the Northern Plains [ Time Frame: No time point ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01265212 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prevalence of Human Papillomavirus in Men Living in the Northern Plains
Prevalence of Human Papillomavirus in Men Living in the Northern Plains

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 prevelance of HPV infection in men living in South Dakota. Because American Indian men have a higher prevalence and death rate due to prostate cancer, the investigators are specifically including this group of men in the study.

Prostate cancer is a major health problem among American Indian men. Recent studies indicate marked prostate cancer disparity among American Indian men in South Dakota compared to the Caucasian population in United States (1.86 times higher mortality due to prostate cancer). In terms of incidence and mortality American Indian men are suffering from prostate cancer at a rate similar to African-American men. While there has been a concentrated effort to reduce prostate cancer mortality in the African American population; no efforts have been initiated to improve upon the prostate cancer disparity in the American Indian population. According to the researchers, this is the first prostate cancer study which is focused on American Indian men. This study is aimed to determine why prostate cancer is so highly prevalent in American Indian men. Recent studies have suggested a link between HPV infection and prostate cancer and a recent study from the group demonstrated very high incidence of HPV infection in American Indian women, suggesting that American Indian men are equally exposed to HPV infection due to the sexually transmitted nature of the disease. Additionally, smoking is a known risk factor for prostate cancer and the American Indian population has a high incidence of smoking. Taken together, the high rates of HPV infection and smoking have prompted us to determine the association of HPV infection with prostate cancer in American Indian men. Information gained from this proposal will lead to advanced understanding of the role of HPV infection and smoking in the pathogenesis of prostate cancer. This study will also determine if HPV infection is a risk factor for the development of prostate cancer in American Indian men.

The potential study participant will be identified while at a routine physician visit and asked if he would like to participate in a research study. If yes, the questions for eligibility will be asked. If eligible, a clinic nurse will explain the details of the study to the potential participant and the participant will be allowed to consent or to decline. If consent is obtained, the participant will answer the epidemiology questionnaire in a private interview with a clinic nurse. The participant will allow the participating physician to take samples from his genital area using 3 moistened Dacron swabs (similar to Q-tips) while in a private examination room. The 3 areas are: 1) the glans of the penis, 2) the shaft of the penis and 3) the scrotum. This process will not be invasive or painful and will take less than 2 minutes. The study participant has ended his role in the study at this time and will not be contacted further. After the samples are collected, each swab will be placed into a pre-labeled container and stored at -20C (freezer temperature). The samples, consents and questionnaire will be batch shipped to the laboratory. At the laboratory, the sample will be processed for DNA/RNA analysis (PCR based technology) which will determine the presence or absence of HPV DNA as well as determine the type of HPV present (high or low risk genotypes). This information will be used to determine the prevalence of HPV infection in men living in South Dakota.

The investigators expect to learn the prevalence of HPV infection in South Dakotan men. This information is important because of the connection between HPV infection and the development of cancer. HPV is well known for its role in cervical cancer and cancers of the head and neck. There is a growing body of literature suggesting that HPV infection may also play a role in the development of other cancers, including prostate cancer. American Indian men suffer from prostate cancer at a greater frequency and severity than Caucasian men; therefore, the investigators have specifically included this group of men in the sample. The HPV prevalency data will be used in combination with laboratory experiments and examination of prostate cancer tissues to examine the association between HPV and prostate cancer.

Observational
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

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

Probability Sample

Male residents of South Dakota.

Human Papillomavirus Infection
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
October 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

-

Male
18 Years to 65 Years
Yes
Contact: Diane Maher, PhD diane.maher@sanfordhealth.org
United States
 
NCT01265212
IISP ID: 37392
No
Diane Maher, Sanford Health
Sanford Health
Not Provided
Principal Investigator: Diane Maher, PhD Sanford Health
Sanford Health
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP