Cervical CarcinomaVALTRIHPNCT05193669
Clinical Validation of Molecular Triage in HR-HPV Positive Women
An observational study of Cervical Carcinoma, run by Hiantis Srl at 1 site in Italy.
Trial summary
Women accessing the HPV-based screening programme for primary screening, will undergo cervical sampling and clinical data recording. Samples from high-risk HPV positive women (around 2000 expected) will be aliquoted for testing with new HPV molecular test, that will allow full genotyping and viral load quantification. Read more about this study
- Who is it for?
- Ages 25 to 64 years, women only
- Conditions the study is for
- Cervical Carcinoma
- How many people
- 23,941 participants
- Where
- 1 siteItaly
- Study dates
- 14 Apr 2021to 30 Nov 2023
- Phase
- Observational
- 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 25 to 64 years
- Women only
- No healthy volunteers
- Adult
Study population: Women accessing the HPV-based screening programme 'Prevenzione Serena', for primary screening, supported by a comprehensive follow-up registry.
Who may be able to join
- women participating in a cervical cancer screening program using an HPV assay as primary screening test
- positivity to hrHPV;
- written informed consent given.
Who cannot join
- total hysterectomy;
- diagnosis of CIN2+ in the last two years;
- hrHPV negative or inadequate.
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOU Città della Salute e della Scienza di Torino S.S.D. Epidemiologia, Screening- CPO
Torino, 10123
About this study
Official title: VALidation of Tests Usable as a First Step TRIage to Manage Women Positive to High-risk Papillomavirus
Women accessing the HPV-based screening programme for primary screening, will undergo cervical sampling and clinical data recording. Samples from high-risk HPV positive women (around 2000 expected) will be aliquoted for testing with new HPV molecular test, that will allow full genotyping and viral load quantification.
- Conditions
- Cervical Carcinoma
- Keywords
- molecular HPV test, Pap-test, Triage
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the index triage test: Pap-test
Sensitivity of the index triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage and relative sensitivity (index vs comparator)
Measured: Baseline
Sensitivity of the index and comparator triage test: HPV molecular test
Sensitivity of the index and comparator triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage + delayed triage; and relative sensitivity (index vs comparator).
Measured: Baseline
Specificity of the index and comparator triage test
Specificity of the index and comparator triage test(s) performed at the time of reflex testing for <CIN2 considered at the time of reflex triage accepting negative colposcopy at the time of reflex testing and double negative index triage testing (reflex and delayed) as an acceptable proxy for <CIN2 and relative specificity for <CIN2 (index vs comparator).
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start14 Apr 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 23,941 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiantis Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Commission, Sciensano, University of Milano Bicocca
- Responsible party
- Sponsor
- Investigators
- Paola Armaroli, MD, Principal investigator, AOU Città della Salute e della Scienza di Torino, ItayMarc Arbyn, MD, Study director, Sciensano - Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193669
- Sponsor's protocol ID
- WP7-HPVONC
- Acronym
- VALTRIHP
- Status last verified
- Feb 2023
- First submitted
- 11 Dec 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VALidation of Tests Usable as a First Step TRIage to Manage Women Positive to High-risk Papillomavirus
- ClinicalTrials.gov ID
- NCT05193669
- Acronym / sponsor ID
- VALTRIHP / WP7-HPVONC
- Conditions
- Cervical Carcinoma
- Keywords
- molecular HPV test, Pap-test, Triage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 23,941 participants (actual)
- Lead sponsor
- Hiantis SrlIndustry (pharma, biotech, devices)
- Collaborators
- European Commission, Sciensano, University of Milano Bicocca
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 18 Jan 2022 (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.
Women accessing the HPV-based screening programme for primary screening, will undergo cervical sampling and clinical data recording. Samples from high-risk HPV positive women (around 2000 expected) will be aliquoted for testing with new HPV molecular test, that will allow full genotyping and viral load quantification.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women accessing the HPV-based screening programme 'Prevenzione Serena', for primary screening, supported by a comprehensive follow-up registry.
Key inclusion criteria (3 listed)
- women participating in a cervical cancer screening program using an HPV assay as primary screening test
- positivity to hrHPV;
- written informed consent given.
Key exclusion criteria (3 listed)
- total hysterectomy;
- diagnosis of CIN2+ in the last two years;
- hrHPV negative or inadequate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of the index triage test: Pap-test
Time frame: Baseline
Sensitivity of the index triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage and relative sensitivity (index vs comparator)
Sensitivity of the index and comparator triage test: HPV molecular test
Time frame: Baseline
Sensitivity of the index and comparator triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage + delayed triage; and relative sensitivity (index vs comparator).
Specificity of the index and comparator triage test
Time frame: Month 12
Specificity of the index and comparator triage test(s) performed at the time of reflex testing for <CIN2 considered at the time of reflex triage accepting negative colposcopy at the time of reflex testing and double negative index triage testing (reflex and delayed) as an acceptable proxy for <CIN2 and relative specificity for <CIN2 (index vs comparator).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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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.
Paola Armaroli, MD principal investigator
AOU Città della Salute e della Scienza di Torino, Itay
Marc Arbyn, MD study director
Sciensano - Brussels, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Carcinoma, run by Hiantis Srl at 1 site in Italy.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Feb 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 Italy. 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?
Results are not available in the source record.
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?
Sensitivity of the index triage test: Pap-test (time frame: Baseline). The study lists 3 primary outcomes in all. 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 8 Feb 2023.