Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV Infection
| Tracking Information | |||||
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| First Received Date ICMJE | July 25, 2007 | ||||
| Last Updated Date | July 27, 2012 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of Responders with High-risk Sexual Behaviors [ Time Frame: 1 month for mailing and return of questionnaires ] [ Designated as safety issue: No ] 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 |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00508170 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV Infection | ||||
| Official Title ICMJE | Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV Infection | ||||
| Brief Summary | Primary Objectives:
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Questionnaire
The questionnaire contains 23 questions and is estimated to take approximately 10 minutes to complete. |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 252 | ||||
| Completion Date | January 2010 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: n/a |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00508170 | ||||
| Other Study ID Numbers ICMJE | 2005-0519 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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