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NCT01384370 · ClinicalTrials.gov registry record
APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results
A clinical trial, sponsored by Gen-Probe, Incorporated.
- Completed
- Registry status
- 1,260
- Enrollment target
NCT01384370: Completed study, sponsored by Gen-Probe, Incorporated.
NCT01384370 is a clinical trial that has completed, run by Gen-Probe, Incorporated. The registered enrollment target is 1,260 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01384370 has completed, sponsored by Gen-Probe, Incorporated.
- COMPLETED
- Registry status
- 1,260 participants
- Enrollment target
Study Summary
In both the ASC-US Study and Adjunct Study populations, the objectives are to: * evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and * evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45 in women with APTIMA HPV Assay positive results.
Primary Outcome
Sensitivity (%) = TP/(TP + FN) x 100: True Negative (TN): AHPVGT=Negative, Cervical Disease Status \<CIN2; True Positive (TP): AHPVGT=Positive, Cervical Disease Status CIN2+; False Positive (FP): AHPVGT=Positive, Cervical Disease Status \<CIN2; False Negative (FN): AHPVGT=Negative, Cervical Disease Status CIN2+; Indeterminate: AHPVGT= Invalid, Cervical Disease Status Any; AHPVGT = APTIMA HPV 16 18/45 Genotype Assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,260 participants |
| Start Date | 2011-06 |
| Est. Completion | 2011-08 |
What the finished NCT01384370 record still lists
NCT01384370 is an observational study that tracks outcomes without assigning an intervention. Its 1,260 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01384370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01384370 about?
NCT01384370 is a clinical study titled "APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results". In both the ASC-US Study and Adjunct Study populations, the objectives are to: * evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and * evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types...
What is the current status of trial NCT01384370?
This trial is currently completed. The enrollment target is 1,260 participants. The study started on 2011-06. Estimated completion is 2011-08.
Who is sponsoring clinical trial NCT01384370?
This trial is sponsored by Gen-Probe, Incorporated, which has 12 total clinical trials registered on ClinicalTrials.gov.
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