Human Papilloma Virus InfectionNCT06111911
Detection of High-Risk HPV in Urine and Cervical Swab Specimen Using HPV Diagnostic Kit (Bio Farma)
A study testing HPV Diagnostic Kit (Bio Farma) in people with Human Papilloma Virus Infection, run by PT Bio Farma at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus Infection
- What is being tested?
- HPV Diagnostic Kit (Bio Farma)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2022to 29 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sexually active female aged 20-50 years
- Willing to participate in study and signed the informed consent form.
Who cannot join
- Pregnant women
- History of HIV infection
- On menstruation period
- History of complete HPV vaccination
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Human Papilloma Virus Infection
- Being tested
- HPV Diagnostic Kit (Bio Farma)
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Diagnostic Kit (Bio Farma)Diagnostic test
Also called COBAS 6800 HPV from Roche Molecular Systems
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.
| Study group | Role | What they receive |
|---|---|---|
| Urine Specimen | Experimental | Not described Receives: Diagnostic Test: HPV Diagnostic Kit (Bio Farma) |
| Cervical Swab Specimen | Experimental | Not described Receives: Diagnostic Test: HPV Diagnostic Kit (Bio Farma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample
Sensitivity and Specificity of HPV Diagnostic Kita (Bio Farma)
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Apr 2022
- Primary completion29 Oct 2022
- Study completion29 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111911
- Sponsor's protocol ID
- Protokol-BIO-HPV14-BIOFARMA
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06111911
- Acronym / sponsor ID
- Protokol-BIO-HPV14-BIOFARMA
- Conditions
- Human Papilloma Virus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 29 Oct 2022 (actual)
- Study completion
- 29 Oct 2022 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urine Specimen | Experimental | Diagnostic Test: HPV Diagnostic Kit (Bio Farma) |
| Cervical Swab Specimen | Experimental | Diagnostic Test: HPV Diagnostic Kit (Bio Farma) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sexually active female aged 20-50 years
- Willing to participate in study and signed the informed consent form.
Key exclusion criteria (4 listed)
- Pregnant women
- History of HIV infection
- On menstruation period
- History of complete HPV vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV Diagnostic Kit (Bio Farma)Also: COBAS 6800 HPV from Roche Molecular SystemsUrine 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. | Diagnostic test | Cervical Swab Specimen, Urine Specimen |
Primary outcome
Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample
Time frame: 0 days
Sensitivity and Specificity of HPV Diagnostic Kita (Bio Farma)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV Diagnostic Kit (Bio Farma) in people with Human Papilloma Virus Infection, run by PT Bio Farma at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample (time frame: 0 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.