Status:

COMPLETED

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

Lead Sponsor:

PT Bio Farma

Conditions:

Human Papilloma Virus Infection

Eligibility:

FEMALE

20-50 years

Phase:

NA

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-...

Eligibility Criteria

Inclusion

  • Sexually active female aged 20-50 years
  • Willing to participate in study and signed the informed consent form.

Exclusion

  • Pregnant women
  • History of HIV infection
  • On menstruation period
  • History of complete HPV vaccination

Key Trial Info

Start Date :

April 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 29 2022

Estimated Enrollment :

900 Patients enrolled

Trial Details

Trial ID

NCT06111911

Start Date

April 1 2022

End Date

October 29 2022

Last Update

November 1 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

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Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia, 10430

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