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Sexual Behavior in Head and Neck Cancer Patients

NCT ID: NCT00662662

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2022-05-31

Brief Summary

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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

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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.

Conditions

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Oropharyngeal Cancer Head and Neck Cancer Squamous Cell Carcinoma

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oropharyngeal Cancer

Questionnaire

Intervention Type BEHAVIORAL

The questionnaire contains 18 questions and is estimated to take approximately 10-15 minutes to complete.

Non-Oropharyngeal Cancer

Questionnaire

Intervention Type BEHAVIORAL

The questionnaire contains 18 questions and is estimated to take approximately 10-15 minutes to complete.

Interventions

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Questionnaire

The questionnaire contains 18 questions and is estimated to take approximately 10-15 minutes to complete.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erich Sturgis, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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2007-0485

Identifier Type: -

Identifier Source: org_study_id