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Human Papillomavirus (HPV) Testing to Improve Cervical Cancer Screening in the Mississippi Delta

NCT00443313 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 664

Last updated 2018-04-05

No results posted yet for this study

Summary

Background:

* Cancer of the cervix (bottom third of the uterus, or womb) can be prevented by regular Pap tests (also called Pap smears), which check for changes in the cells of the cervix. Because many women in the United States have regular Pap smears, cervical cancer is not common in this country. However, the disease is common among women in the Mississippi Delta because of poor participation in screening programs.
* The major causes of cervical cancer are persistent human papillomaviruses (HPV) infection by cancer-associated HPV types and lack of screening. These viruses cause an infection that often goes away by itself, but if it does not go away, over a long time lead to cervical cancer. HPV causes cervical abnormalities, which are detected by Pap smears and then treated.

Objectives:

-To determine whether an at-home self-collection method for obtaining cells from the cervix can be a simple, safe and inexpensive way to screen for cervical cancer for women who don t go to the health clinic regularly.

Eligibility:

* Women who reside in the counties of Leflore, Sunflower, Washington or Tallahatchie, Mississippi.
* Women between 26 and 65 years of age who are not pregnant and who have not had a hysterectomy.

Design:

Screening study participants undergo the following:

* The doctor takes a cervical sample using the same self-collection device that women will use at home to self-collect.
* Pelvic examination and Pap test. For this test, the woman lies on an exam table and the doctor inserts an instrument called a speculum into the vagina, opening it to see the cervix. A special brush is used to take a few cells from the cervix. The cells are placed on a glass slide and sent to a lab for examination.
* Cervical cell specimen collection using an at-home self-collection kit that participants will use at home after 2 weeks
* At-home self-collection by participant after 2 weeks.
* Referral to a doctor for follow-up care, if needed.
* Colposcopy (see below) in all women with a Pap test that is abnormal or positive for HPV and for some women with a normal smear.

Colposcopy study participants undergo the following:

* The doctor takes a cervical sample using the same self-collection device that women will use at home to self-collect.
* Colposcopy, an exam in which the doctor examines the cervix using a light and looks through a magnifying device to see if there is any abnormal tissue on the cervix. During this exam, the doctor may remove a small sample of tissue to diagnose any abnormality. Participants also have a sample collected using the self-collection kit.
* At-home cervical sample collection by participant after 2 weeks.
* Notification if further medical care is required and treatment if the biopsy looks abnormal.

Conditions

  • Cervical Intraepithelial Neoplasia

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Julia C Gage, Ph.D. · National Cancer Institute (NCI)

Eligibility

Min Age
26 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-24
Completion
2015-06-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00443313 on ClinicalTrials.gov