Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Low-Cost Molecular Cervical Cancer Screening Study
NCT01231945 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 7,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with HPV appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01231945 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Washington, Beijing Municipality. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01231945?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.