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NCT06111911 Clinical Trial

Detection of High-Risk HPV in Urine and Cervical Swab Specimen Using HPV Diagnostic Kit (Bio Farma)

Human Papilloma Virus Infection Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06111911
Other study ID # Protokol-BIO-HPV14-BIOFARMA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date October 29, 2022

Study information
Verified date October 2023
Source PT Bio Farma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 900
Est. completion date October 29, 2022
Est. primary completion date October 29, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• HPV Diagnostic Kit (Bio Farma)
Urine samples (30 ml): collected from each subjects using urine pot. Cervical swab: collected from each subject using cyto brush and stored in special container which preservatives fluid.

Locations
Country Name City State
Indonesia Cipto Mangunkusumo Hospital Jakarta DKI Jakarta

Sponsors (1)
Lead Sponsor Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample Sensitivity and Specificity of HPV Diagnostic Kita (Bio Farma) 0 days
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