Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Human Papillomavirus (HPV) Testing to Improve Cervical Cancer Screening in the Mississippi Delta
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), October 2008
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00443313
  Purpose

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.

Condition
Uterine Cervical Cancer

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: HPV Testing to Improve Cervical Cancer Screening in the Mississippi Delta (Mississippi Delta Project)

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1000
Study Start Date: January 2007
Detailed Description:

Cytology screening programs have effectively reduced cervical cancer incidence and mortality in the U.S. and other developed countries by less than 75%. However, cervical cancer remains the second most common cancer and the second leading cause of cancer-related mortality in women because of ineffective or no screening in the medically underserved populations. Cervical cytology is insensitive and must be repeated frequently to achieve programmatic effectiveness, i.e., the annual Pap smear; cytology-based programs in this country cost an estimated $6 billion annually. Thus, given its inefficiency, cervical cytology is unlikely to impact cervical cancer rates in underserved populations. Screening based on human papillomavirus (HPV) DNA testing is a more sensitive alternative to cytology and might be combined with self-collection to permit cost-efficient wider coverage screening than cytology alone in the populations underserved by cytology-based programs. To examine the technical feasibility of combining self-collection with HPV DNA testing as a clinically acceptable alternative to cytology, the investigators propose a study in the Mississippi Delta, a medically underserved population, in collaboration with the Mississippi State Department of Health, Cancer Prevention and Cancer Epidemiology and Genetics, and Center for Reducing Cancer Health Disparities. They will recruit 1,000 women, 500 attending colposcopy due to cytologic abnormality, 250 women who regularly attend a screening clinic, and 250 unscreened women who have not had a Pap smear within the last 3 years, to participate in a screening or colposcopy visit and in a self-collection at home.

Three clinical specimens will be collected from each woman: 1) a physician-collected cervicovaginal specimen (for HPV testing) using the self-sampling device (Dacron swab); 2) a physician-collected cervical specimen (for cytology and HPV testing) using standard clinical collection methods; and 3) a woman (self)-collected cervicovaginal specimen using a self-sampling device at home two weeks after the clinical visit and retuned via mail. They will compare the clinical performance of HPV DNA testing of self-collected specimens to that of cytology for detection of histologically confirmed cervical intraepithelial neoplasia grade 2 (CIN2) or more severe (greater than CIN2). A comparable or superior sensitivity, with adequate specificity and patient acceptability, of self-collection plus HPV DNA testing compared with cytology will guide whether this technique could be broadly introduced for cervical cancer screening.

  Eligibility

Ages Eligible for Study:   26 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Five-hundred women attending colposcopy and 500 women receiving cytology screening, including 250 unscreened women, will be recruited for the study. Non-pregnant, non-hysterectomized women aged 26-65 will be recruited.

EXCLUSION CRITERIA:

Women under 26 or over 65 years of age.

Pregnant women or women having given birth to a child in the past 8 weeks. To insure women included in the study are not pregnant, we will ask women during the consenting process if they are pregnant. Women who answer yes for either query will be excluded. Participants will also receive a reminder call for their 2-week self-collection. At that time, women again will be asked if they are pregnant. If any woman answers yes, she will be instructed to not self-collect.

Women who have had a total hysterectomy.

Women who have an overt cancerous lesion visible upon exam by the clinician.

Other reasons to exclude women include the inability to speak English, the appearance of mental incompetence, or refusal to participate or sign the informed consent form.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443313

Contacts
Contact: Phillip Castle, Ph.D. (301) 435-3976 castlep@mail.nih.gov

Locations
United States, Mississippi
Mississiippi State Department of Health Recruiting
Jackson, Mississippi, United States
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 999907080, 07-C-N080
Study First Received: March 2, 2007
Last Updated: October 29, 2008
ClinicalTrials.gov Identifier: NCT00443313  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Carcinogenic HPV
Cytology
Cervical Intraepithelial Neoplasis Grade 2 and 3
ASCUS
LSIL
Cervical Cancer Screening

Study placed in the following topic categories:
Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009