Last updated on August 2018

Prevalence of Anal Dysplasia and Anal Cancer in Women With Cervical Vaginal and Vulvar Dysplasia and Cancer


Brief description of study

The goal of this clinical research study is to learn how often high-grade dysplasia or invasive squamous cell carcinoma of the anus occurs in women with high-grade dysplasia invasive squamous cell carcinoma, invasive adenocarcinoma, or AIS of the cervix, vagina, or vulva.

This is an investigational study.

Up to 500 women will take part in this study. Up to 250 will be enrolled at MD Anderson. Up to 250 will be enrolled at the Harris Health System.

Detailed Study Description

Anal cancer as well as cervical, vaginal, vulvar, and oropharyngeal cancer (cancer in the throat) can be caused by an infection called human papillomavirus (HPV). Researchers do not know how often anal or oropharyngeal cancer and dysplasia occur together with cervical, vaginal or vulvar high-grade dysplasia, or invasive squamous cell carcinoma . All of these diseases are caused by the HPV virus and for this reason are thought to be related. Researchers also want to learn how to test for these diseases.

If you agree to take part in this study, the following tests and procedures will be performed either during your scheduled colposcopy as part of a clinic visit, or during your scheduled surgery. These tests are performed to test for pre-cancer of the anal canal.

  • During your scheduled pelvic exam, 3 cervical/vaginal swabs will be collected for research testing. Two (2) are for HPV research, and one is related to bacteria in the cervix/vagina.
  • You will have an anal pap test. To perform this test, 1 small swab is placed in your anal canal to collect cells, similar to the pap test performed on your cervix/vagina. Three (3) additional samples will be collected, including 2 for HPV research, and 1 for research testing related to bacteria in the rectum.
  • Two (2) mouth rinse samples will be collected for research testing related to oral HPV. For each sample, you will swish with mouthwash for 15 seconds, gargle for 15 seconds, and spit into a sample cup.
  • If you have an abnormal test result, you will be referred for additional standard-of-care diagnostic procedures.

Data related to HPV related dysplasia and cancer may be collected for up to 5 years. After that, your study participation will be over.

Clinical Study Identifier: NCT02140021

Contact Investigators or Research Sites near you

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Kathleen Schmeler, MD

Lyndon B. Johnson General Hospital
Houston, TX United States
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Kathleen Schmeler, MD

University of Texas MD Anderson Cancer Center
Houston, TX United States
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