Head and Neck CancerNCT00897273
Oral HPV Infection in Young Men
An observational study of Head and Neck Cancer and Infection, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Trial summary
RATIONALE: Gathering information about human papillomavirus infection of the mouth in young men may help doctors learn more about risk factors for oropharyngeal cancer. PURPOSE: This research study is assessing human papillomavirus infection of the mouth in young men and risk factors for oropharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 to 21 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer, Infection, Precancerous Condition
- What is being tested?
- comparative genomic hybridization, gene expression analysis and study of socioeconomic and demographic variables
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- May 2007to 5 May 2009
- 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 21 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: A convenience sample of 500 men recruited from Baltimore-area college health centers (Johns Hopkins University, University of Maryland, or Towson University).
DISEASE CHARACTERISTICS:
- Currently enrolled at one of the following institutions:
- Johns Hopkins University
- University of Maryland
- Towson University
PATIENT CHARACTERISTICS:
- Able to understand the procedures and the potential risks involved as determined by clinic staff
PRIOR CONCURRENT THERAPY:
- No prior Gardasil® off label
About this study
Official title: Human Papillomavirus Infection of the Mouth in Young Men and Risk Factors for Oropharyngeal Cancer
RATIONALE: Gathering information about human papillomavirus infection of the mouth in young men may help doctors learn more about risk factors for oropharyngeal cancer.
PURPOSE: This research study is assessing human papillomavirus infection of the mouth in young men and risk factors for oropharyngeal cancer.
Read the detailed description
OBJECTIVES:
- Estimate the prevalence of oral human papillomavirus (HPV) type 16, 18, 6, or 11 infection in young adult men.
- Assess the independent effect of distinct sexual practices, including kissing, oral sex, and vaginal intercourse, on oral HPV prevalence.
- Estimate the 6-month incidence of HPV infection in this study population.
OUTLINE: Participants are assessed for oral human papillomavirus virus (HPV) infection (i.e., types 16, 18, 6, and 11) and for known or potential risk factors associated with the infection, including sexual behavior (e.g., kissing, performing oral sex, or vaginal intercourse), demographic characteristics (e.g., age or race), and history of HPV or other sexually transmitted infections. Prior exposure to HPV vaccine is also assessed.
Oral rinse samples are collected from participants at baseline and at 6 months for detection of HPV genomic DNA in oral exfoliated cells. Baseline serum samples are also collected.
- Conditions
- Head and Neck Cancer, Infection, Precancerous Condition
- Being tested
- comparative genomic hybridization, gene expression analysis, study of socioeconomic and demographic variables, evaluation of cancer risk factors, study of high risk factors
- Keywords
- recurrent squamous cell carcinoma of the oropharynx, oropharyngeal cancer, oropharyngeal squamous cell carcinoma, infection, precancerous condition, human papilloma virus infection
- Medical subject headings
- Head and Neck Neoplasms, Infections, Precancerous Conditions, Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparative genomic hybridizationGenetic
gene expression analysisGenetic
study of socioeconomic and demographic variablesOther
evaluation of cancer risk factorsProcedure or surgery
study of high risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of an oral human papillomavirus (HPV) type 16, 18, 6 or 11 infection
Measured: 2 years
Presence of oral HPV infection by any of 37 HPV types
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2007
- Primary completionMay 2009
- Study completion5 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Maura Gillison, MD, PhD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897273
- Sponsor's protocol ID
- J0729
- Other IDs
- P30CA006973, NA_00009472, JHOC-J0729, CDR0000554422
- Status last verified
- Apr 2013
- First submitted
- 9 May 2009
- Last updated
- 17 Jan 2019
- Results posted
- No
Publications
Gillison ML. Human papillomavirus-related diseases: oropharynx cancers and potential implications for adolescent HPV vaccination. J Adolesc Health. 2008 Oct;43(4 Suppl):S52-60. doi: 10.1016/j.jadohealth.2008.07.002.
PubMed 18809146
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus Infection of the Mouth in Young Men and Risk Factors for Oropharyngeal Cancer
- ClinicalTrials.gov ID
- NCT00897273
- Acronym / sponsor ID
- J0729
- Conditions
- Head and Neck Cancer, Infection, Precancerous Condition
- Keywords
- recurrent squamous cell carcinoma of the oropharynx, oropharyngeal cancer, oropharyngeal squamous cell carcinoma, infection, precancerous condition, human papilloma virus infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2007
- Primary completion
- May 2009 (actual)
- Study completion
- 5 May 2009 (actual)
- First posted
- 12 May 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.
RATIONALE: Gathering information about human papillomavirus infection of the mouth in young men may help doctors learn more about risk factors for oropharyngeal cancer.
PURPOSE: This research study is assessing human papillomavirus infection of the mouth in young men and risk factors for oropharyngeal cancer.
Detailed description
OBJECTIVES:
- Estimate the prevalence of oral human papillomavirus (HPV) type 16, 18, 6, or 11 infection in young adult men.
- Assess the independent effect of distinct sexual practices, including kissing, oral sex, and vaginal intercourse, on oral HPV prevalence.
- Estimate the 6-month incidence of HPV infection in this study population.
OUTLINE: Participants are assessed for oral human papillomavirus virus (HPV) infection (i.e., types 16, 18, 6, and 11) and for known or potential risk factors associated with the infection, including sexual behavior (e.g., kissing, performing oral sex, or vaginal intercourse), demographic characteristics (e.g., age or race), and history of HPV or other sexually transmitted infections. Prior exposure to HPV vaccine is also assessed.
Oral rinse samples are collected from participants at baseline and at 6 months for detection of HPV genomic DNA in oral exfoliated cells. Baseline serum samples are also collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 21 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A convenience sample of 500 men recruited from Baltimore-area college health centers (Johns Hopkins University, University of Maryland, or Towson University).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparative genomic hybridization | Genetic | – |
| gene expression analysis | Genetic | – |
| study of socioeconomic and demographic variables | Other | – |
| evaluation of cancer risk factors | Procedure or surgery | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
Presence of an oral human papillomavirus (HPV) type 16, 18, 6 or 11 infection
Time frame: 2 years
Presence of oral HPV infection by any of 37 HPV types
Time frame: 2 years
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 17 Jan 2019.
- Results publication: PubMed 18809146Gillison ML. Human papillomavirus-related diseases: oropharynx cancers and potential implications for adolescent HPV vaccination. J Adolesc Health. 2008 Oct;43(4 Suppl):S52-60. doi: 10.1016/j.jadohealth.2008.07.002.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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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.
Maura Gillison, MD, PhD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Infection, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Presence of an oral human papillomavirus (HPV) type 16, 18, 6 or 11 infection (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT00897273, which also lists 1 linked publication.
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 17 Jan 2019.