Status:
COMPLETED
Human Papillomavirus (HPV) Testing to Improve Cervical Cancer Screening in the Mississippi Delta
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
26-65 years
Brief 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 ma...
Detailed Description
Background: Cytology screening programs have effectively reduced cervical cancer incidence and mortality in the U.S. by greater than 75%. However, these programs requiring repeated clinician-administe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 24 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 25 2015
Estimated Enrollment :
664 Patients enrolled
Trial Details
Trial ID
NCT00443313
Start Date
January 24 2007
End Date
June 25 2015
Last Update
April 5 2018
Active Locations (1)
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1
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892