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

Sponsor
PT Bio Farma (Industry)
Overall Status
Completed
CT.gov ID
NCT06111911
Collaborator
(none)
900
Enrollment
1
Location
2
Arms
6.9
Actual Duration (Months)
129.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: HPV Diagnostic Kit (Bio Farma)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
900 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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)
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Oct 29, 2022
Actual Study Completion Date :
Oct 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Urine Specimen

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.
Other Names:
  • COBAS 6800 HPV from Roche Molecular Systems

    		•
    Experimental: Cervical Swab Specimen

    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.
    Other Names:
  • COBAS 6800 HPV from Roche Molecular Systems

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample [0 days]

      Sensitivity and Specificity of HPV Diagnostic Kita (Bio Farma)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cipto Mangunkusumo Hospital Jakarta DKI Jakarta Indonesia 10430

    Sponsors and Collaborators

    • PT Bio Farma

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PT Bio Farma
    ClinicalTrials.gov Identifier:
    NCT06111911
    Other Study ID Numbers:
    • Protokol-BIO-HPV14-BIOFARMA
    First Posted:
    Nov 1, 2023
    Last Update Posted:
    Nov 1, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Papillomavirus Infections
    Papilloma

    Study Results

    No Results Posted as of Nov 1, 2023