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NCT00662662 Clinical Trial

Sexual Behavior in Head and Neck Cancer Patients

Head and Neck Cancer Clinical Trial

Official title:
Sexual Behavior in Head and Neck Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00662662
Other study ID # 2007-0485
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 2008
Est. completion date May 31, 2022

Study information
Verified date December 2020
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). Knowing this information could help doctors better teach patients about avoiding certain risk factors, which may help to prevent the disease.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1500
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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. 2. Must have the ability to understand and provide informed consent. 3. Patients must be 18 years and older. 4. Ability to read, write, and speak English. 5. Resident of the United States. 6. Agrees to have tumor tissue, if available, tested for HPV. No additional biopsy will be requested. Exclusion Criteria: 1. Previous cancer diagnosis excluding non-melanoma skin cancer. 2. Blood transfusion within the previous 6 months. 3. Immune suppression, such as HIV disease or immune-suppressing therapy (i.e., steroids).

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Questionnaire
The questionnaire contains 18 questions and is estimated to take approximately 10-15 minutes to complete.

Locations
Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 6 Years
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