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Spots Global Cancer Trial Database for Natural History of HPV Infection in Men: The HIM Study

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Natural History of HPV Infection in Men: The HIM Study

Official Title: Natural History of HPV Infection in Men: The HIM Study

Study ID: NCT00786760

Study Description

Brief Summary: 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.

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: Yes

Locations

H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, Florida, United States

Contact Details

Name: Anna Giuliano, Ph.D.

Affiliation: H. Lee Moffitt Cancer Center and Research Institute, Inc.

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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