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

NCT ID: NCT06111911

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-10-29

Brief Summary

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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 (COBASĀ® 6800 HPV from Roche Molecular Systems) RT-PCR based in urine and cervical swab specimens.

Detailed Description

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Conditions

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Human Papilloma Virus Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Urine Specimen

Group Type EXPERIMENTAL

HPV Diagnostic Kit (Bio Farma)

Intervention Type DIAGNOSTIC_TEST

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.

Cervical Swab Specimen

Group Type EXPERIMENTAL

HPV Diagnostic Kit (Bio Farma)

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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COBAS 6800 HPV from Roche Molecular Systems

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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PT Bio Farma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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Protokol-BIO-HPV14-BIOFARMA

Identifier Type: -

Identifier Source: org_study_id

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