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NCT00709891 · ClinicalTrials.gov registry record · NA
Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease
A NA study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- NA
- Development phase
- 47,208
- Enrollment target
NCT00709891 is a NA study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 47,208 participants.
The verdict
NCT00709891, a NA study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- NA
- Development phase
- 47,208 participants
- Enrollment target
Study Summary
This study provided data on the performance of the Cobas® 4800 HPV Test for identifying histologically confirmed high-grade cervical disease. The baseline, cross-sectional phase was conducted in approximately 45,000 women undergoing routine cervical cancer screening, of whom approximately 7,400 were selected to undergo colposcopy and biopsy/endocervical curettage (ECC) at baseline. These subjects included women with cytology that is 'not normal' and a selection of those with 'normal' cytology who entered a follow-up phase and underwent cytological evaluation annually for 3 years. In this follow-up phase, colposcopy and biopsy/ECC were performed only in women with cervical cytology considered 'not normal' at any of the annual follow-up visits.
Interventions
- DEVICE cobas® 4800 HPV Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47,208 participants |
| Start Date | 2008-05 |
| Est. Completion | 2013-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00709891
The ClinicalTrials.gov registry entry for NCT00709891 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 47,208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which cobas® 4800 HPV Test is the first listed.
NCT00709891 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00709891 about?
NCT00709891 is a clinical study titled "Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease". This study provided data on the performance of the Cobas® 4800 HPV Test for identifying histologically confirmed high-grade cervical disease. The baseline, cross-sectional phase was conducted in approximately 45,000 women undergoing routine cervical cancer screening, of whom approximately 7,400 were...
What is the current status of trial NCT00709891?
This trial is currently completed. It is a NA study. The enrollment target is 47,208 participants. The study started on 2008-05. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00709891?
The interventions under investigation include: cobas® 4800 HPV Test (DEVICE).
Who is sponsoring clinical trial NCT00709891?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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