Head and Neck CancerNCT00508170
Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV Infection
An observational study of Head and Neck Cancer and Oropharyngeal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To determine whether high-risk sexual behaviors are more common in patients with oropharyngeal cancer than in patients with head and neck cancers of other sub-sites. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oropharyngeal Cancer, Human Papillomavirus Infection
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jan 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosed squamous cell carcinoma of the head and neck that participated in the molecular epidemiology study LAB00-062 of head and neck cancer between 1995 and 2005.
Who may be able to join
- Patients with diagnosed squamous cell carcinoma of the head and neck that participated in the molecular epidemiology study LAB00-062 of head and neck cancer between 1995 and 2005.
- Head and Neck cancer participants of LAB00-062 that are still alive.
- Head and Neck cancer participants of LAB00-062 that have known mailing addresses in the U.S.A.
- Patients must be 18 years and older.
- Patients will have completed their primary treatment but may be undergoing treatment for a second primary or recurrent disease.
- Ability to read, write, and speak Spanish or English.
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
Primary Objectives:
- To determine whether high-risk sexual behaviors are more common in patients with oropharyngeal cancer than in patients with head and neck cancers of other sub-sites.
- To determine if high-risk sexual behaviors are more common in patients with HPV (human papillomavirus) associated head and neck cancer than those without evidence of HPV-16 infection.
Read the detailed description
Squamous cell cancer of the head and neck (SCCHN) is believed to be caused by the long-term exposure of the mucous membrane on the inside of the mouth to different types of cancer-causing agents. This results in changes in the mouth, which can lead to the development of cancer.
Infection with HPV-16 has been linked with SCCHN. Half of all cancers of the oropharynx (the middle part of the throat including the soft palate, base of the tongue, and tonsils) are caused by HPV-16. HPV-16 is normally sexually transmitted, and is the cause of cervical cancer in women. By finding out if the virus is also sexually transmitted to the oropharynx, doctors may be able to educate patients about risk factors for developing cancer in this region. Eventually, doctors may be able to vaccinate people who are at risk for getting this virus.
You have received this questionnaire because you gave researchers your verbal consent for the mail-out. Along with the questionnaire, included are 2 self-addressed stamped envelopes for you to return the questionnaire and consent separately.
If you agree to take part in this study, you will complete the questionnaire about your sexual history such as specific sexual practices and number of partners, exposure to HPV and other viruses, and any relevant medical history. This questionnaire should take about 10 minutes to complete. The questionnaire will be given a study code number so that your name or M. D. Anderson patient ID number will not appear on the questionnaire.
Once you have finished the questionnaire, for added privacy and confidentiality, you should place the signed consent form in 1 self-addressed stamped envelope (SASE) and the completed questionnaire into the other self-addressed stamped envelope (SASE) that has been provided. Please mail both envelopes back within 15 days of receiving the questionnaire.
Once you have completed the questionnaire, your participation in this study is over.
This is an investigational study. About 1,267 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.
- Being tested
- Questionnaire
- Keywords
- Head and Neck Cancer, Human Papillomavirus Infection, Oropharyngeal Patients, Sexual Behavior, Questionnaire
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms, Papillomavirus Infections, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
The questionnaire contains 23 questions and is estimated to take approximately 10 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Oropharyngeal Cancer | Not described Receives: Behavioral: Questionnaire | |
| Patients with Non-Oropharyngeal Cancer | Not described Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Responders with High-risk Sexual Behaviors
Written self-administered questionnaire responses analyzed to determine whether patients with oropharyngeal cancer have history of high-risk sexual behavior (defined as 15 or more lifetime sexual partners) greater than that of patients with tumors of other sites of head and neck
Measured: 1 month for mailing and return of questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startMar 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erich Sturgis, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508170
- Sponsor's protocol ID
- 2005-0519
- Status last verified
- Jul 2012
- First submitted
- 25 Jul 2007
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV Infection
- ClinicalTrials.gov ID
- NCT00508170
- Acronym / sponsor ID
- 2005-0519
- Keywords
- Head and Neck Cancer, Human Papillomavirus Infection, Oropharyngeal Patients, Sexual Behavior, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 27 Jul 2007 (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.
Primary Objectives:
- To determine whether high-risk sexual behaviors are more common in patients with oropharyngeal cancer than in patients with head and neck cancers of other sub-sites.
- To determine if high-risk sexual behaviors are more common in patients with HPV (human papillomavirus) associated head and neck cancer than those without evidence of HPV-16 infection.
Detailed description
Squamous cell cancer of the head and neck (SCCHN) is believed to be caused by the long-term exposure of the mucous membrane on the inside of the mouth to different types of cancer-causing agents. This results in changes in the mouth, which can lead to the development of cancer.
Infection with HPV-16 has been linked with SCCHN. Half of all cancers of the oropharynx (the middle part of the throat including the soft palate, base of the tongue, and tonsils) are caused by HPV-16. HPV-16 is normally sexually transmitted, and is the cause of cervical cancer in women. By finding out if the virus is also sexually transmitted to the oropharynx, doctors may be able to educate patients about risk factors for developing cancer in this region. Eventually, doctors may be able to vaccinate people who are at risk for getting this virus.
You have received this questionnaire because you gave researchers your verbal consent for the mail-out. Along with the questionnaire, included are 2 self-addressed stamped envelopes for you to return the questionnaire and consent separately.
If you agree to take part in this study, you will complete the questionnaire about your sexual history such as specific sexual practices and number of partners, exposure to HPV and other viruses, and any relevant medical history. This questionnaire should take about 10 minutes to complete. The questionnaire will be given a study code number so that your name or M. D. Anderson patient ID number will not appear on the questionnaire.
Once you have finished the questionnaire, for added privacy and confidentiality, you should place the signed consent form in 1 self-addressed stamped envelope (SASE) and the completed questionnaire into the other self-addressed stamped envelope (SASE) that has been provided. Please mail both envelopes back within 15 days of receiving the questionnaire.
Once you have completed the questionnaire, your participation in this study is over.
This is an investigational study. About 1,267 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Oropharyngeal Cancer | – | Behavioral: Questionnaire |
| Patients with Non-Oropharyngeal Cancer | – | Behavioral: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed squamous cell carcinoma of the head and neck that participated in the molecular epidemiology study LAB00-062 of head and neck cancer between 1995 and 2005.
Key inclusion criteria (6 listed)
- Patients with diagnosed squamous cell carcinoma of the head and neck that participated in the molecular epidemiology study LAB00-062 of head and neck cancer between 1995 and 2005.
- Head and Neck cancer participants of LAB00-062 that are still alive.
- Head and Neck cancer participants of LAB00-062 that have known mailing addresses in the U.S.A.
- Patients must be 18 years and older.
- Patients will have completed their primary treatment but may be undergoing treatment for a second primary or recurrent disease.
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| QuestionnaireThe questionnaire contains 23 questions and is estimated to take approximately 10 minutes to complete. | Behavioural | Patients with Non-Oropharyngeal Cancer, Patients with Oropharyngeal Cancer |
Primary outcome
Number of Responders with High-risk Sexual Behaviors
Time frame: 1 month for mailing and return of questionnaires
Written self-administered questionnaire responses analyzed to determine whether patients with oropharyngeal cancer have history of high-risk sexual behavior (defined as 15 or more lifetime sexual partners) greater than that of patients with tumors of other sites of head and neck
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 30 Jul 2012.
- UT MD Anderson Cancer CenterLink 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.
Erich Sturgis, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Oropharyngeal Cancer, run by M.D. Anderson Cancer Center at 1 site 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 6 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 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of Responders with High-risk Sexual Behaviors (time frame: 1 month for mailing and return of questionnaires). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2012.