Sexual Behavior in Head and Neck Cancer Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00662662 |
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Recruitment Status
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Active, not recruiting
First Posted
: April 21, 2008
Last Update Posted
: February 22, 2018
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| Condition or disease | Intervention/treatment |
|---|---|
| Oropharyngeal Cancer Head and Neck Cancer Squamous Cell Carcinoma | Behavioral: Questionnaire |
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 Type : | Observational |
| Estimated Enrollment : | 1500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Sexual Behavior in Head and Neck Cancer Patients |
| Actual Study Start Date : | April 2008 |
| Estimated Primary Completion Date : | April 2019 |
| Estimated Study Completion Date : | April 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Oropharyngeal Cancer |
Behavioral: Questionnaire
The questionnaire contains 18 questions and is estimated to take approximately 10-15 minutes to complete.
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| Non-Oropharyngeal Cancer |
Behavioral: Questionnaire
The questionnaire contains 18 questions and is estimated to take approximately 10-15 minutes to complete.
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- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662662
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Erich Sturgis, MD | M.D. Anderson Cancer Center |
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00662662 History of Changes |
| Other Study ID Numbers: |
2007-0485 |
| First Posted: | April 21, 2008 Key Record Dates |
| Last Update Posted: | February 22, 2018 |
| Last Verified: | February 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by M.D. Anderson Cancer Center:
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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 |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Oropharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Squamous Cell Neoplasms by Site Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |