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Status unknownNCT00662662Updated Dec 30, 2020

Sexual Behavior in Head and Neck Cancer Patients

An observational study in Oropharyngeal Cancer, Head and Neck Cancer and Squamous Cell Carcinoma, sponsored by M.D. Anderson Cancer Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-30.

Sponsored by M.D. Anderson Cancer Center · Observational

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

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

Keywords

  • 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
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)

Groups and cohorts

  • Oropharyngeal Cancer

    Behavioral: Questionnaire

  • Non-Oropharyngeal Cancer

    Behavioral: Questionnaire

Interventions

  • BehavioralQuestionnaire

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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00662662
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Apr 21, 2008
Start date
Apr 2008
Primary completion
May 31, 2022 (estimated)
Completion
May 31, 2022 (estimated)
Last update
Dec 30, 2020

Study contacts

Erich Sturgis, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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