Sexual Behavior in Head and Neck Cancer Patients

• Conditions: Oropharyngeal Cancer; Squamous Cell Carcinoma; Head and Neck Cancer
• Interventions: Behavioral: Questionnaire

• Registration Number: NCT00662662
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-21
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-29
• Last Update Posted: 2020-12-30
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Oropharyngeal Cancer	Questionnaire	-
Oropharyngeal Cancer	Questionnaire	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States