Infections

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Sexually Transmitted Diseases

Papillomavirus Infections

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

Prospectively assess HPV infection in a large cohort of men in the US , Mexico, and Brazil representing countries of low and high risk.

Cohort: 3000 men examined every 6 months for 4 years.

Pilot study: 150 men examined every 6 months for 4 years.

Anna Giuliano, Ph.D.

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.

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.

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.

Natural History of HPV Infection in Men: The HIM Study

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).

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.

National Cancer Institute (NCI)

H. Lee Moffitt Cancer Center and Research Institute

Neoplasms

Mouth and Tooth Diseases

Rare Diseases

Mouth Neoplasms

Oral Cancer

Lip and Oral Cavity Cancer

Gypsyamber D'Souza, PhD

Recently human papillomavirus (HPV) has been recognized to cause some oropharyngeal (tonsil) cancer. But very little is known about oral HPV infection and risk factors. This study will evaluate how common oral HPV infection is, what sexual behaviors are associated with risk for infection, and how long infections tend to last.

18-25 year old individuals are being recruited from STD clinics in Baltimore County and followed every three months for this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Natural History of HPV Infection in Men: The HIM Study	NCT00786760	Human Papilloma...	Cohort: 3000 me... Pilot study: 15...	18 Years - 70 Years	H. Lee Moffitt Cancer Center and Research Institute
Study of Oral Papillomavirus In Teens and Twenties	NCT00994019	STD		18 Years - 26 Years	Johns Hopkins Bloomberg School of Public Health

Spots Global Cancer Trial Database for std

Every month we try and update this database with for std cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for std

Every month we try and update this database with for std cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for std cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.