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NCT01231945 · ClinicalTrials.gov registry record
Low-Cost Molecular Cervical Cancer Screening Study
A clinical trial of Hpv and Uterine Cervical Neoplasms, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 7,500
- Enrollment target
- 2
- Study locations
NCT01231945 is a study of Hpv and Uterine Cervical Neoplasms that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 7,500 participants, above the 1,929-participant average among 24 other Hpv trials with a reported enrollment target (289% higher). The trial reports 2 study locations across 2 states.
The verdict
NCT01231945, a study of Hpv and Uterine Cervical Neoplasms, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 7,500 participants
- Enrollment target
- 2
- Study locations
Study Summary
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..
Conditions Studied
Study Locations (2)
Washington
- PATH - Seattle
Beijing Municipality
- CICAMS - Beijing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,500 participants |
| Start Date | 2010-10-11 |
| Est. Completion | 2010-12-20 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01231945
The ClinicalTrials.gov registry entry for NCT01231945 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 7,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,929-participant average among 24 other Hpv trials with a reported enrollment target (289% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Hpv appearing as the primary indexed condition, and to 0 interventions.
NCT01231945 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Washington, Beijing Municipality.
Frequently Asked Questions
What is clinical trial NCT01231945 about?
NCT01231945 is a clinical study titled "Low-Cost Molecular Cervical Cancer Screening Study". 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 d...
What is the current status of trial NCT01231945?
This trial is currently completed. The enrollment target is 7,500 participants. The study started on 2010-10-11. Estimated completion is 2010-12-20.
What conditions does trial NCT01231945 study?
This clinical trial studies the following conditions: Hpv, Uterine Cervical Neoplasms, DNA Probes, E6 Protein.
Who is sponsoring clinical trial NCT01231945?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01231945 being conducted?
This trial has 2 study locations across Washington, Beijing Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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