Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Infectious Disease, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/5/2019 |
| Start Date: | October 2014 |
| End Date: | May 2019 |
The purpose of the study is to assess the cumulative disease detection of greater than or
equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical
intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV
status and cytology status from the BDS-USHPV baseline results
equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical
intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV
status and cytology status from the BDS-USHPV baseline results
Inclusion Criteria:
- Subject enrolled into the protocol BDS-USHPV and identified as eligible for the
longitudinal protocol • Subjects enrolled into protocol BDS-USHPV with a baseline
colposcopy and biopsy procedure and not treated.
Exclusion Criteria:
- Subjects with prior complete or partial hysterectomy involving removal of the cervix
- Subjects on whom conization, LEEP, cervical laser surgery, or cryosurgery has been
performed since enrollment into the BDS-USHPV study
- Year 3 visit can not exceed 3 years and 6 months from the baseline visit
We found this trial at
40
sites
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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