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Sexual Behavior in Head and Neck Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Oropharyngeal Cancer, Head and Neck Cancer, Squamous Cell Carcinoma

Thank you

Trial Information

Sexual Behavior in Head and Neck Cancer Patients


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.


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).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome 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).

Outcome Time Frame:

6 Years

Safety Issue:

No

Principal Investigator

Erich Sturgis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0485

NCT ID:

NCT00662662

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Oropharyngeal Cancer
  • Head and Neck Cancer
  • Squamous Cell Carcinoma
  • 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
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Oropharyngeal Neoplasms

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030