Natural History of HPV Infection in Men: The HIM Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00786760
First received: November 5, 2008
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to learn about the natural history of Human Papillomavirus (HPV) infection in men. The study will also find out what factors are linked to HPV in men including other sexually transmitted diseases (STDs). If participants test positive for syphilis, gonorrhea or chlamydia, we are required by law to report the results to the Florida Department of Health. Participants will be able to get free medical treatment from the Florida Department of Health for these STDs. Participants will be given a written report of the results of the STD testing.


Condition Intervention
Human Papillomavirus
Other: Cohort: 3000 men examined every 6 months for 4 years.
Other: Pilot study: 150 men examined every 6 months for 4 years.

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Natural History of HPV Infection in Men: The HIM Study

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Cohort Selection [ Time Frame: 3 years, 3 months ] [ Designated as safety issue: No ]
    The first specific aim is to establish the cohort of 3000 men ages 18 - 44 years who will be examined every 6 months for 4 years. To assess potential biases introduced by the run-in visit, Pearson's χ² test of association will be used to compare cohort participants and non-participants who attended the run-in visit with respect to known and potential HPV risk factors and HPV status. All analyses will be conducted using Intercooled STATA (StataCorp. 2001. Stata Statistical Software: Release 8.2 SE College Station, Texas: Stata Corporation).


Secondary Outcome Measures:
  • Incidence Rates of Specific HPV Type Infection [ Time Frame: 4 years per participant ] [ Designated as safety issue: No ]
    The second specific aim is to determine the incidence and persistence of type-specific HPV infections. Estimates of the incidence rates of specific HPV type infection will be calculated on the basis of the number of cases in which a given type is detected for the first time in men who tested negative for that HPV type at baseline.


Biospecimen Retention:   Samples With DNA

This study will create a specimen repository with which to test future novel hypotheses related to HPV infection among men. To assess other genetic, infectious, or environmental factors that may influence acquisition and persistence of HPV infections in men, whole blood, serum, exfoliated penile cell samples, and oral cells will be stored in aliquots for future analyses as funding becomes available. Using banked specimens preserved for DNA, RNA, and protein analyses, we will be able to assess novel biomarkers such as methylation status of oncogenic HPV, polymorphisms in genes involved in innate immunity (e.g., TLR genes), and mRNA of the E6 and E7 HPV oncoproteins in the future.


Enrollment: 1431
Study Start Date: June 2005
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1. Men ages 18 - 44 years Other: Cohort: 3000 men examined every 6 months for 4 years.
Prospectively assess HPV infection in a large cohort of men in the US , Mexico, and Brazil representing countries of low and high risk.
2. Men ages 45 - 70 years Other: Pilot study: 150 men examined every 6 months for 4 years.
Prospectively assess HPV infection in a large cohort of men in the US , Mexico, and Brazil representing countries of low and high risk.

Detailed Description:

The study protocol will include a pre-enrollment run-in visit, a baseline visit (enrollment), and 8 additional visits after enrollment scheduled 6 months apart. Intervals of every 6 months were chosen to insure that both acquisition and loss of infections may be assessed, as studies in women indicate that median duration of oncogenic infections ranges between 7-9 months. Informed consent will occur during the run-in visit. The run-in and follow-up visits will include questionnaire administration, visual inspection of the skin and external genitalia, and the collection of urine, blood, oral cells, and penile skin samples If anogenital lesions are present at any of the clinic visits, they will be sampled as well.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  1. Men ages 18-44; a pilot study group, ages 45-70;
  2. residents of 3 sites - southern Florida, US, Sao Paulo, Brazil, or state of Morelos, Mexico
  3. report no prior diagnosis of penile or anal cancers
  4. have never been diagnosed with genital and anal warts
  5. have not participated in a HPV vaccine study
  6. report no prior diagnosis with acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
  7. report no current penile discharge or burning during urination
  8. are not currently being treated for a sexually transmitted disease
  9. have not been imprisoned or homeless during the last 6 months
  10. have not been in drug treatment during the last 6 months
  11. no plan to relocate in the next 4 years
  12. willing to comply with 10 scheduled visits every 6 months for 4 years
Criteria

Inclusion Criteria:

  • Men between 18 and 70 years of age, living in Southern Florida, US; Sao Paulo, Brazil; or state of Morelos, Mexico.
  • Participant has never been told that they have penile or anal cancer or genital warts.
  • Willing to attend scheduled visits every 6 months in the next 4 years.

Exclusion Criteria:

  • Prospective participants with symptoms of any STD (excluding HPV) during screening will not be eligible to participate in the study until the STD (Sexually Transmitted Disease) infection is gone.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786760

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Anna Giuliano, Ph.D. H. Lee Moffitt Cancer Center and Research Institute, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00786760     History of Changes
Other Study ID Numbers: MCC-13930, NCI CA098803-01a1
Study First Received: November 5, 2008
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
HPV
Papillomavirus
Infection
Sexually transmitted disease
STD

ClinicalTrials.gov processed this record on August 28, 2014