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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00508170 |
Primary Objectives:
Condition | Intervention |
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Head and Neck Cancer Oropharyngeal Cancer Human Papillomavirus Infection |
Behavioral: Questionnaire |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
Official Title: | Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV Infection |
Estimated Enrollment: | 1267 |
Study Start Date: | March 2006 |
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. There will be no cost to you for taking part in this study. About 1,267 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Erich Sturgis, MD | U.T.M.D. Anderson Cancer Center |
Study ID Numbers: | 2005-0519 |
Study First Received: | July 25, 2007 |
Last Updated: | September 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00508170 History of Changes |
Health Authority: | United States: Institutional Review Board |
Head and Neck Cancer Human Papillomavirus Infection Oropharyngeal Patients Sexual Behavior Questionnaire |
Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Skin Diseases Pharyngeal Neoplasms Pharyngeal Diseases Virus Diseases Skin Diseases, Infectious |
Warts Head and Neck Neoplasms Papillomavirus Infections DNA Virus Infections Stomatognathic Diseases Oropharyngeal Neoplasms |
Communicable Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Skin Diseases Tumor Virus Infections Pharyngeal Neoplasms Infection Pharyngeal Diseases Virus Diseases Skin Diseases, Viral |
Neoplasms Skin Diseases, Infectious Warts Neoplasms by Site Head and Neck Neoplasms Papillomavirus Infections DNA Virus Infections Stomatognathic Diseases Oropharyngeal Neoplasms |