Sexual Behavior in Head and Neck Cancer Patients

December 29, 2020 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Oropharyngeal Cancer
Behavioral: Questionnaire
The questionnaire contains 18 questions and is estimated to take approximately 10-15 minutes to complete.
Non-Oropharyngeal Cancer
Behavioral: Questionnaire
The questionnaire contains 18 questions and is estimated to take approximately 10-15 minutes to complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Erich Sturgis, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2008

Primary Completion (Anticipated)

May 31, 2022

Study Completion (Anticipated)

May 31, 2022

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Actual)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 29, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0485

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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