Sexual Behavior in Head and Neck Cancer Patients

This study is currently recruiting participants.
Verified March 2013 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00662662
First received: April 17, 2008
Last updated: March 5, 2013
Last verified: March 2013

April 17, 2008
March 5, 2013
April 2008
April 2014   (final data collection date for primary 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). [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
The goal of this behavioral research study is 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00662662 on ClinicalTrials.gov Archive Site
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Sexual Behavior in Head and Neck Cancer Patients
Sexual Behavior in Head and Neck Cancer Patients

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Approximately 600 oropharynx study participants and 900 non-oropharynx study participants.

  • Oropharyngeal Cancer
  • Head and Neck Cancer
  • Squamous Cell Carcinoma
Behavioral: Questionnaire
The questionnaire contains 18 questions and is estimated to take approximately 10-15 minutes to complete.
  • Oropharyngeal Cancer
    Intervention: Behavioral: Questionnaire
  • Non-Oropharyngeal Cancer
    Intervention: Behavioral: Questionnaire
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
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April 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: Erich Sturgis, MD 713-792-6920
United States
 
NCT00662662
2007-0485
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Erich Sturgis, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP