Oropharyngeal CancerNCT00662662
Sexual Behavior in Head and Neck Cancer Patients
An observational study of Oropharyngeal Cancer and Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this behavioral research study is to learn if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Cancer, Head and Neck Cancer, Squamous Cell Carcinoma
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to 31 May 2022
- 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: Approximately 600 oropharynx study participants and 900 non-oropharynx study participants.
Who may be able to join
- Patients with newly diagnosed, previously untreated squamous cell carcinoma of the head and neck (SCCHN) who are candidates for the molecular epidemiology study LAB00-062 of head and neck cancer.
- Must have the ability to understand and provide informed consent.
- Patients must be 18 years and older.
- Ability to read, write, and speak English.
- Resident of the United States.
- Agrees to have tumor tissue, if available, tested for HPV. No additional biopsy will be requested.
Who cannot join
- Previous cancer diagnosis excluding non-melanoma skin cancer.
- Blood transfusion within the previous 6 months.
- Immune suppression, such as HIV disease or immune-suppressing therapy (i.e., steroids).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this behavioral research study is to learn if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). Knowing this information could help doctors better teach patients about avoiding certain risk factors, which may help to prevent the disease.
Read the detailed description
SCCHN is believed to be caused by different types of viruses being exposed to the mucous membrane on the inside of the mouth, throat, and voice box, over a long period of time. This exposure results in changes in the cells of the mouth, throat, and voice box, which can lead to the development of cancer.
HPV-16 has been linked to SCCHN. Half of all cancers of the oropharynx (the middle part of the throat, the base of the tongue, and tonsils) may be caused by HPV-16. HPV-16 is normally spread sexually, and is one of the main causes of cervical cancer in women. By finding out if the virus is also spread sexually to the throat, doctors may be able to teach patients about risk factors for developing cancer in this area.
Study Procedures:
If you agree to take part in this study, you will be asked to complete a questionnaire about your sexual history, such as specific sexual practices, number of partners, exposure to HPV and other viruses, and any medical history related to HPV-16. The questionnaire will take 10-15 minutes to complete.
None of your personal identifying information will be attached to your questionnaire, and the questionnaire will be assigned a one-of-a-kind study code number.
To check your cancer diagnosis, your medical records will be reviewed.
Length of Study:
Once you have completed the questionnaire, your participation in this study is over.
This is an investigational study.
Up to 1,500 patients will be enrolled in this study. All will be enrolled at MD Anderson.
- Being tested
- Questionnaire
- Keywords
- Oropharyngeal Cancer, Non-Oropharyngeal Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, Squamous cell carcinoma of the head and neck, SCCHN, HPV-16, Questionnaire, Sexual Behavior, Survey
- Medical subject headings
- Oropharyngeal Neoplasms, Head and Neck Neoplasms, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck, 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 18 questions and is estimated to take approximately 10-15 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Oropharyngeal Cancer | Not described Receives: Behavioral: Questionnaire | |
| 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.
To find out if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16).
Measured: 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal 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
- 1,500 participants (estimated)
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, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662662
- Sponsor's protocol ID
- 2007-0485
- Status last verified
- Dec 2020
- First submitted
- 17 Apr 2008
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Behavior in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT00662662
- Acronym / sponsor ID
- 2007-0485
- Keywords
- Oropharyngeal Cancer, Non-Oropharyngeal Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, Squamous cell carcinoma of the head and neck, SCCHN, HPV-16, Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2008 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 21 Apr 2008 (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.
The goal of this behavioral research study is to learn if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). Knowing this information could help doctors better teach patients about avoiding certain risk factors, which may help to prevent the disease.
Detailed description
SCCHN is believed to be caused by different types of viruses being exposed to the mucous membrane on the inside of the mouth, throat, and voice box, over a long period of time. This exposure results in changes in the cells of the mouth, throat, and voice box, which can lead to the development of cancer.
HPV-16 has been linked to SCCHN. Half of all cancers of the oropharynx (the middle part of the throat, the base of the tongue, and tonsils) may be caused by HPV-16. HPV-16 is normally spread sexually, and is one of the main causes of cervical cancer in women. By finding out if the virus is also spread sexually to the throat, doctors may be able to teach patients about risk factors for developing cancer in this area.
Study Procedures:
If you agree to take part in this study, you will be asked to complete a questionnaire about your sexual history, such as specific sexual practices, number of partners, exposure to HPV and other viruses, and any medical history related to HPV-16. The questionnaire will take 10-15 minutes to complete.
None of your personal identifying information will be attached to your questionnaire, and the questionnaire will be assigned a one-of-a-kind study code number.
To check your cancer diagnosis, your medical records will be reviewed.
Length of Study:
Once you have completed the questionnaire, your participation in this study is over.
This is an investigational study.
Up to 1,500 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oropharyngeal Cancer | – | Behavioral: Questionnaire |
| 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
- Approximately 600 oropharynx study participants and 900 non-oropharynx study participants.
Key inclusion criteria (6 listed)
- Patients with newly diagnosed, previously untreated squamous cell carcinoma of the head and neck (SCCHN) who are candidates for the molecular epidemiology study LAB00-062 of head and neck cancer.
- Must have the ability to understand and provide informed consent.
- Patients must be 18 years and older.
- Ability to read, write, and speak English.
- Resident of the United States.
Key exclusion criteria (3 listed)
- Previous cancer diagnosis excluding non-melanoma skin cancer.
- Blood transfusion within the previous 6 months.
- Immune suppression, such as HIV disease or immune-suppressing therapy (i.e., steroids).
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 18 questions and is estimated to take approximately 10-15 minutes to complete. | Behavioural | Non-Oropharyngeal Cancer, Oropharyngeal Cancer |
Primary outcome
To find out if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16).
Time frame: 6 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink 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
M.D. 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 Oropharyngeal Cancer and Head and Neck 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 3 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: status not confirmed, as of the sponsor's last update on 30 Dec 2020. 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?
Results are not available in the source record.
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?
To find out if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). (time frame: 6 Years). 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 Dec 2020.