NCT00443313

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

Completed Last updated 5 April 2018

What this trial tests

trial in Cervical Intraepithelial Neoplasia in 664 participants. Completed in 25 June 2015.

Timeline

24 January 2007

25 June 2015

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	664
Start date	24 January 2007
Estimated completion	25 June 2015
Sites	1 location across United States

Conditions studied

• Cervical Intraepithelial Neoplasia — all drugs for Cervical Intraepithelial Neoplasia →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 26 to 65, female only, with Cervical Intraepithelial Neoplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.