Clinical trial NCT00662662: Sexual Behavior in Head and Neck Cancer Patients
Official title: Sexual Behavior in Head and Neck Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oropharyngeal Cancer
Head and Neck Cancer
Squamous Cell Carcinoma
Keywords: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2008-04-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 600 oropharynx study participants and 900 non-oropharynx study participants.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: 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).
timeFrame: 6 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Erich Sturgis, MD
role: PRINCIPAL_INVESTIGATOR
References: