Clinical trial · Interventional
Detection of High-Risk HPV in Urine and Cervical Swab Specimen Using HPV Diagnostic Kit (Bio Farma)
Detection of High-Risk Human Papilloma Virus in Urine and Cervical Swab Specimens; Comparison Between HPV Diagnostic Kit (Bio Farma) and COBAS 6800 HPV (Roche Molecular Systems)
NCT06111911CI-TRIAL-00070967completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a cross-sectional study to evaluate accuracy of high-risk DNA-HPV testing using HPV Diagnostic Kit (Bio Farma) compared to Standard Kit (COBAS® 6800 HPV from Roche Molecular Systems) RT-PCR based in urine and cervical swab specimens.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papilloma Virus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV Diagnostic Kit (Bio Farma) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Urine Specimen
- interventionNames
- Diagnostic Test: HPV Diagnostic Kit (Bio Farma)
- type
- EXPERIMENTAL
- label
- Cervical Swab Specimen
- interventionNames
- Diagnostic Test: HPV Diagnostic Kit (Bio Farma)
Primary outcomes (1)
- measure
- Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample
- timeFrame
- 0 days
- description
- Sensitivity and Specificity of HPV Diagnostic Kita (Bio Farma)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Sexually active female aged 20-50 years * Willing to participate in study and signed the informed consent form. Exclusion Criteria: * Pregnant women * History of HIV infection * On menstruation period * History of complete HPV vaccination
References
Publications (0)
Data not yet available
No reference posted for this study.