STDSPITTNCT00994019
Study of Oral Papillomavirus In Teens and Twenties
An observational study of STD, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- STD
- How many people
- 550 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: High risk young adults
Who may be able to join
- Age 18 -26 years
Who cannot join
- Never received HPV vaccine (Gardasil or Cervarix)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baltimore County Woodlawn Health Centers
Baltimore, Maryland, 21207
Baltimore County Eastern Health Center
Baltimore, Maryland, 21237
About this study
Official title: 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.
Read the detailed description
18-25 year old individuals are being recruited from STD clinics in Baltimore County and followed every three months for this study.
- Conditions
- STD
- Keywords
- HPV, oral cancer, young adults
- Medical subject headings
- Mouth Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral HPV infection
Oral rinse samples collected prospectively for 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for STDStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gypsyamber D'Souza, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Gypsyamber D'Souza, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994019
- Sponsor's protocol ID
- 2422
- Acronym
- SPITT
- Status last verified
- Jan 2020
- First submitted
- 13 Oct 2009
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26908748D'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.
PubMed 25256827
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Natural History of Oral HPV Infection Among Young Adults
- ClinicalTrials.gov ID
- NCT00994019
- Acronym / sponsor ID
- SPITT / 2422
- Conditions
- STD
- Keywords
- HPV, oral cancer, young adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- High risk young adults
Key inclusion criteria (1 listed)
- Age 18 -26 years
Key exclusion criteria (1 listed)
- Never received HPV vaccine (Gardasil or Cervarix)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oral HPV infection
Time frame: 24 months
Oral rinse samples collected prospectively for 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Results publication: PubMed 26908748D'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.
- Results publication: PubMed 25256827D'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gypsyamber D'Souza, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STD, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral HPV infection (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00994019, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.