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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: Completed NA study, sponsored by Hoffmann-La Roche.
NCT00709891 is a NA study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 47,208 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (3265% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A diagnosis of ≥ CIN2 (cervical intraepithelial neoplasia) included histology results of CIN2, CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.
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 |
What the finished NCT00709891 record still lists
NCT00709891 is an interventional study that assigns participants to a tested intervention. Its 47,208 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (3265% higher).
The record links to 0 conditions, and to 1 intervention - of which cobas® 4800 HPV Test is the first listed.
NCT00709891 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00709891's enrollment target sits among peer trials
47,208 7th of 2000 higher than 1,994 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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