- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00994019
Study of Oral Papillomavirus In Teens and Twenties (SPITT)
January 6, 2020 updated by: Gypsyamber D'Souza, Johns Hopkins Bloomberg School of Public Health
Short-term Natural History of Oral HPV Infection Among Young Adults
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.
Study Overview
Status
Completed
Conditions
Detailed Description
18-25 year old individuals are being recruited from STD clinics in Baltimore County and followed every three months for this study.
Study Type
Observational
Enrollment (Actual)
550
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21207
- Baltimore County Woodlawn Health Centers
-
Baltimore, Maryland, United States, 21237
- Baltimore County Eastern Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 26 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
High risk young adults
Description
Inclusion Criteria:
- Age 18 -26 years
Exclusion Criteria:
- Never received HPV vaccine (Gardasil or Cervarix)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral HPV infection
Time Frame: 24 months
|
Oral rinse samples collected prospectively for 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- D'Souza G, Wentz A, Kluz N, Zhang Y, Sugar E, Youngfellow RM, Guo Y, Xiao W, Gillison ML. Sex Differences in Risk Factors and Natural History of Oral Human Papillomavirus Infection. J Infect Dis. 2016 Jun 15;213(12):1893-6. doi: 10.1093/infdis/jiw063. Epub 2016 Feb 10.
- D'Souza G, Kluz N, Wentz A, Youngfellow RM, Griffioen A, Stammer E, Guo Y, Xiao W, Gillison ML. Oral Human Papillomavirus (HPV) Infection among Unvaccinated High-Risk Young Adults. Cancers (Basel). 2014 Aug 14;6(3):1691-704. doi: 10.3390/cancers6031691.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
October 1, 2014
Study Completion (ACTUAL)
October 1, 2014
Study Registration Dates
First Submitted
October 13, 2009
First Submitted That Met QC Criteria
October 13, 2009
First Posted (ESTIMATE)
October 14, 2009
Study Record Updates
Last Update Posted (ACTUAL)
January 9, 2020
Last Update Submitted That Met QC Criteria
January 6, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2422
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.