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Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV Infection
This study is ongoing, but not recruiting participants.
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508170
  Purpose

Primary Objectives:

  1. To determine whether high-risk sexual behaviors are more common in patients with oropharyngeal cancer than in patients with head and neck cancers of other sub-sites.
  2. To determine if high-risk sexual behaviors are more common in patients with HPV (human papillomavirus) associated head and neck cancer than those without evidence of HPV-16 infection.

Condition Intervention
Head and Neck Cancer
Oropharyngeal Cancer
Human Papillomavirus Infection
 Behavioral: Questionnaire

MedlinePlus related topics: Cancer Head and Neck Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV Infection

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment: 1267
Study Start Date: March 2006
Detailed Description:

Squamous cell cancer of the head and neck (SCCHN) is believed to be caused by the long-term exposure of the mucous membrane on the inside of the mouth to different types of cancer-causing agents. This results in changes in the mouth, which can lead to the development of cancer.

Infection with HPV-16 has been linked with SCCHN. Half of all cancers of the oropharynx (the middle part of the throat including the soft palate, base of the tongue, and tonsils) are caused by HPV-16. HPV-16 is normally sexually transmitted, and is the cause of cervical cancer in women. By finding out if the virus is also sexually transmitted to the oropharynx, doctors may be able to educate patients about risk factors for developing cancer in this region. Eventually, doctors may be able to vaccinate people who are at risk for getting this virus.

You have received this questionnaire because you gave researchers your verbal consent for the mail-out. Along with the questionnaire, included are 2 self-addressed stamped envelopes for you to return the questionnaire and consent separately.

If you agree to take part in this study, you will complete the questionnaire about your sexual history such as specific sexual practices and number of partners, exposure to HPV and other viruses, and any relevant medical history. This questionnaire should take about 10 minutes to complete. The questionnaire will be given a study code number so that your name or M. D. Anderson patient ID number will not appear on the questionnaire.

Once you have finished the questionnaire, for added privacy and confidentiality, you should place the signed consent form in 1 self-addressed stamped envelope (SASE) and the completed questionnaire into the other self-addressed stamped envelope (SASE) that has been provided. Please mail both envelopes back within 15 days of receiving the questionnaire.

Once you have completed the questionnaire, your participation in this study is over.

This is an investigational study. There will be no cost to you for taking part in this study. About 1,267 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with diagnosed squamous cell carcinoma of the head and neck that participated in the molecular epidemiology study LAB00-062 of head and neck cancer between 1995 and 2005.
  2. Head and Neck cancer participants of LAB00-062 that are still alive.
  3. Head and Neck cancer participants of LAB00-062 that have known mailing addresses in the U.S.A.
  4. Patients must be 18 years and older.
  5. Patients will have completed their primary treatment but may be undergoing treatment for a second primary or recurrent disease.
  6. Ability to read, write, and speak Spanish or English.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508170

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Erich Sturgis, MD U.T.M.D. Anderson Cancer Center
  More Information

Study ID Numbers: 2005-0519
Study First Received: July 25, 2007
Last Updated: September 25, 2007
ClinicalTrials.gov Identifier: NCT00508170  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Human Papillomavirus Infection
Oropharyngeal Patients
Sexual Behavior
Questionnaire

Study placed in the following topic categories:
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Skin Diseases
Pharyngeal Neoplasms
Pharyngeal Diseases
Virus Diseases
Skin Diseases, Infectious
 Warts
Head and Neck Neoplasms
Papillomavirus Infections
DNA Virus Infections
Stomatognathic Diseases
Oropharyngeal Neoplasms

Additional relevant MeSH terms:
Skin Diseases, Viral
Communicable Diseases
Neoplasms
 Neoplasms by Site
Tumor Virus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009



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