Low-Cost Molecular Cervical Cancer Screening Study

Completed

Conditions studied: DNA Probes, E6 Protein, Uterine Cervical Neoplasms, HPV

In brief

Background: \- Low-cost molecular human papillomavirus (HPV) testing may offer a more robust alternative to Pap smears and visual inspection for cervical cancer screening of underserved women. Two low-cost molecular tests for human HPV, the HPV E6 Test and the careHPV test, have been developed to detect cervical cancer by testing for HPV DNA. These tests take between 2 and 3 hours to run and may provide point-of-care (diagnostic testing at or near the site of patient care) testing for HPV. Researchers are interested in evaluating both tests to determine the best strategy for HPV testing of women who live in rural or underserved areas that have a high prevalence of cervical cancer diagnoses. Objectives: * To evaluate the clinical performance of the HPV E6 Test and careHPV in detecting cervical cancer and precancerous lesions. * To evaluate the best low-cost test or combination of tests for women who have been referred for cervical cancer screening or treatment. * To compare the clinical performance of self-collected specimens versus clinician-collected specimens in detecting cervical cancer and precancerous lesions. Eligibility: \- Women between 25 and 65 years of age who live in rural China. Design: * This study involves an initial testing visit and a 1-year followup visit for a high-risk subgroup. * Participants will have the HPV E6 test, careHPV, and a visual inspection test for cervical cancer. For comparison, participants will also have the standard HPV test approved by the U.S. Food and Drug Administration. * Participants who test positive for HPV on any of the above tests will also have colposcopy to collect samples of cervical tissue for further study. * A random sample of women who test negative for HPV will also have colposcopy. Participants may also have biopsies if there is visual evidence of cervical abnormalities. * At the 1-year followup visit, participants in the high-risk subgroup will have the same tests as in the previous visit..

Key facts

Study ID

NCT01231945

Run by

National Cancer Institute (NCI)

People needed

7500

Starts

2010-10-11

Expected to finish

2010-12-20

Last updated by the study team

2017-07-02

Who can join

Age: 25 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• are not married AND report never having had sexual intercourse 2) have had a total hysterectomy
• have a history of cervical cancer
• are physically or mentally unable to undergo routine cervical cancer screening or unable to provide informed consent.
• are pregnant or have been pregnant in the last month
• Women who are currently menstruating at the time of enrollment will be deferred from participating, and will become eligible to participate 7-14 days after menstruation has ended. The menstruating women will be advised to return for the screening 7 to 14 days after their menstrual period has concluded.

Where it is running

• PATH — Seattle, Washington, United States
• CICAMS — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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