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Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis
NCT06975436 · View on ClinicalTrials.gov ↗
Study Summary
In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500 symptomatic individuals with a clinical presentation consistent with vaginitis, vaginosis, or both. Additionally, a minimum of 100 asymptomatic individuals will also be enrolled in the study. The cobas® BV/CV assay amplifies and detects the deoxyribonucleic acid (DNA) of pathogens associated with bacterial vaginosis (BV) and candida vaginitis (CV). The BV results will be compared with the patient infection status (PIS) established by using 3 Food and Drug Administration (FDA)-cleared commercial assays, and the CV results will be compared with the PIS established with the use of culture plus MALDI-TOF (matrix-assisted laser desorption/ionization time-of-flight). The primary objective of the clinical performance study is to evaluate the performance (sensitivity and specificity) of cobas® BV/CV to determine the presence of BV and/or CV in the intended use patient population when being tested on cobas® 6800/8800 systems. The secondary objective is to evaluate the equivalency of cobas® BV/CV between the cobas® 5800 system and cobas® 6800/8800 systems.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST cobas® BV/CV test
- DIAGNOSTIC_TEST BD Max™ Vaginal Panel
- DIAGNOSTIC_TEST Cepheid Xpert Xpress MVP
- DIAGNOSTIC_TEST Hologic Aptima BV Assay
Study Locations (10)
California
- Matrix Clinical Research — Los Angeles
- M3 Wake Research - San Diego at Convoy — San Diego
North Carolina
- Eastern Carolina Women's Center — New Bern
- Unified Women's Clinical Research/Lyndhurst — Winston-Salem
Other
- Diagnostic Consultative Center "Ascendent" Ltd. — Sofia
- Centre Hospitalier Universitaire Vaudois (Chuv) — Lausanne
Colorado
- Red Rocks OBGYN — Lakewood
Florida
- Altus Research — Lake Worth
Missouri
- Washington University — St Louis
Texas
- Planned Parenthood Gulf Coast — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 738 participants |
| Start Date | 2024-12-30 |
| Est. Completion | 2025-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06975436
The ClinicalTrials.gov registry entry for NCT06975436 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 738 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Bacterial Vaginosis appearing as the primary indexed condition, and to 4 interventions — of which cobas® BV/CV test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06975436 reports 10 study locations spanning 7 distinct geographic areas — top geographies include California, North Carolina, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06975436 about?
NCT06975436 is a clinical study titled "Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis". In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500 symptomatic individuals with a clinical presentation consistent with vaginitis,...
What is the current status of trial NCT06975436?
This trial is currently completed. The enrollment target is 738 participants. The study started on 2024-12-30. Estimated completion is 2025-06-30.
What conditions does trial NCT06975436 study?
This clinical trial studies the following conditions: Bacterial Vaginosis, Candida Vaginitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06975436?
The interventions under investigation include: cobas® BV/CV test (DIAGNOSTIC_TEST), BD Max™ Vaginal Panel (DIAGNOSTIC_TEST), Cepheid Xpert Xpress MVP (DIAGNOSTIC_TEST), Hologic Aptima BV Assay (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06975436?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06975436 being conducted?
This trial has 10 study locations across California, Colorado, Florida, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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