NCT06111911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 26, 2023

Last Update Submit

October 26, 2023

Conditions

Human Papilloma Virus Infection

Outcome Measures

Primary Outcomes (1)

  • Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample

    Sensitivity and Specificity of HPV Diagnostic Kita (Bio Farma)

    0 days

Study Arms (2)

Urine Specimen

EXPERIMENTAL
Diagnostic Test: HPV Diagnostic Kit (Bio Farma)

Cervical Swab Specimen

EXPERIMENTAL
Diagnostic Test: HPV Diagnostic Kit (Bio Farma)

Interventions

HPV Diagnostic Kit (Bio Farma)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.

Also known as: COBAS 6800 HPV from Roche Molecular Systems
Cervical Swab SpecimenUrine Specimen

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 1, 2023

Study Start

April 1, 2022

Primary Completion

October 29, 2022

Study Completion

October 29, 2022

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)