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NCT01234480 · ClinicalTrials.gov registry record
Intended Use Study of the BD SurePath Plus™ Pap
A clinical trial, sponsored by Becton, Dickinson and Company.
- Terminated
- Registry status
- 5,859
- Enrollment target
NCT01234480: Clinical Trial study, sponsored by Becton, Dickinson and Company.
NCT01234480 is a clinical trial that was terminated before completion, run by Becton, Dickinson and Company. The registered enrollment target is 5,859 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01234480 was terminated before completion, sponsored by Becton, Dickinson and Company.
- TERMINATED
- Registry status
- 5,859 participants
- Enrollment target
Study Summary
This study will provide data on the performance of the BD SurePath Plus™ Pap test for identifying high grade cervical disease. This study will be conducted with approximately 12,500 women undergoing routine cervical cancer screening, of whom women with abnormal cytology and/or positive HPV test will be selected to undergo colposcopy and biopsy/ECC. Subjects with abnormal cytology results with biopsy results of less than or equal to CIN1 or CIN2 untreated will be asked to return in 6-8 months for follow-up testing. Subjects may be asked to proceed to a longer-term follow-up study and undergo cytological evaluation annually for 3 years (separate study).
Primary Outcome
Estimate the sensitivity, specificity, positive predictive value and negative predictive value of the BD SurePath Plus Pap test in detecting cervical disease as defined as CIN2 or higher
Interventions
- DEVICE BD SurePath Plus Pap test
- DEVICE BD SurePath Pap test
- PROCEDURE colposcopy with biopsy/ECC
- DEVICE HPV DNA test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,859 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-08 |
Why NCT01234480 stopped before completion
NCT01234480 is an interventional study that assigns participants to a tested intervention. Its 5,859 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 4 interventions - of which BD SurePath Plus Pap test is the first listed.
NCT01234480 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01234480 about?
NCT01234480 is a clinical study titled "Intended Use Study of the BD SurePath Plus™ Pap". This study will provide data on the performance of the BD SurePath Plus™ Pap test for identifying high grade cervical disease. This study will be conducted with approximately 12,500 women undergoing routine cervical cancer screening, of whom women with abnormal cytology and/or positive HPV test will...
What is the current status of trial NCT01234480?
This trial is currently terminated. The enrollment target is 5,859 participants. The study started on 2010-09. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01234480?
The interventions under investigation include: BD SurePath Plus Pap test (DEVICE), BD SurePath Pap test (DEVICE), colposcopy with biopsy/ECC (PROCEDURE), HPV DNA test (DEVICE).
Who is sponsoring clinical trial NCT01234480?
This trial is sponsored by Becton, Dickinson and Company, which has 33 total clinical trials registered on ClinicalTrials.gov.
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