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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00443313 |
Background:
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:
Design:
Screening study participants undergo the following:
Colposcopy study participants undergo the following:
Condition |
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Uterine Cervical Cancer |
Study Type: | Observational |
Official Title: | HPV Testing to Improve Cervical Cancer Screening in the Mississippi Delta (Mississippi Delta Project) |
Estimated Enrollment: | 1000 |
Study Start Date: | January 2007 |
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.
Ages Eligible for Study: | 26 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.
Contact: Phillip Castle, Ph.D. | (301) 435-3976 | castlep@mail.nih.gov |
United States, Mississippi | |
Mississiippi State Department of Health | Recruiting |
Jackson, Mississippi, United States |
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 |
Carcinogenic HPV Cytology Cervical Intraepithelial Neoplasis Grade 2 and 3 |
ASCUS LSIL Cervical Cancer Screening |
Genital Diseases, Female Uterine Cervical Neoplasms Uterine Cervical Diseases Genital Neoplasms, Female |
Uterine Diseases Uterine Neoplasms Urogenital Neoplasms |
Neoplasms Neoplasms by Site |