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Cervical Intraepithelial Neoplasia Grade 2/3EU-VALHUDESNCT04312737

Evaluation of in Vitro Devices on Self-collected Vaginal Swab and Urine Sample for Testing of Human Papilloma Virus

An observational study of Cervical Intraepithelial Neoplasia Grade 2/3 and Neoplasm Cervix, run by Hiantis Srl at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The European VALHUDES study is a Clinical Performance /Diagnostic Test Accuracy Study that aims to evaluate whether HPV testing with new assays performed on self-samples, collected by means of a vaginal and a urine collection device is as accurate to detect cervical pre-cancer as on cliniciantaken cervical samples. Read more about this study

Who is it for?
Ages 25 to 65 years, women only
What is being tested?
Self-Collecting Devices and In Vitro Diagnostic Assays
Type of treatment
Medical device
How many people
600 participants
Where
6 sitesin 3 countries
Study dates
16 Jul 2020to 15 Mar 2022
How long will I take part?
1 Day
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 65 years
  • Women only
  • Adult, Older adult

Study population: Women referred to colposcopy evaluation for any reason [i.e. previous history of abnormal cervical screen test results (cytology, HPV test), previous abnormal colposcopy]

Who may be able to join

  • Women referred to colposcopy evaluation for any reason [i.e. previous history of abnormal cervical screen test results (cytology, HPV test), previous abnormal colposcopy]
  • Ability to understand and sign the informed consent
  • Informed consent given

Who cannot join

  • Age < 25 or > 65 years
  • Past history of hysterectomy
  • Women with known pregnancy
  • Pregnancy within last 3 months
  • Vulnerable patient: a patient who is or may be for any reason unable to take care of him or herself, or unable to protect him or herself against significant harm or exploitation
  • Simultaneous involvement in any other research project

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Italy4 sites

  • Spedali Civili di Brescia

    Brescia

  • European Institute of Oncology

    Milan

  • Dipartimento di Chirurgia e Medicina - Università Milano-Bicocca

    Monza, Monza Brianza

  • ATS-Sardegna Azienda Tutela Salute. ASSL Sassari

    Sassari

Other trials in Italy

Ireland1 site

  • The Coombe Women and Infants University Hospital, & Trinity College

    Dublin

Other trials in Ireland

United Kingdom1 site

  • Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh

    Edinburgh

Other trials in United Kingdom

About this study

Official title: European VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and Urine Samples

The European VALHUDES study is a Clinical Performance /Diagnostic Test Accuracy Study that aims to evaluate whether HPV testing with new assays performed on self-samples, collected by means of a vaginal and a urine collection device is as accurate to detect cervical pre-cancer as on cliniciantaken cervical samples.

Read the detailed description

Women accessing the Colposcopy Centres for a colposcopy examination and fulfilling the selection criteria will be asked, after written informed consent, to self-collect a first-void urine (with the Colli-Pee device) and a vaginal sample (with the FLOQSwab device), prior to undergoing colposcopy. Just before colposcopic examination, a clinician will also take a cervical sample (with a Cervex-Brush using the same procedure normally adopted for cervical cytology and/or HPV testing. During colposcopy, a colposcopy-targeted biopsy may be taken if appropriate. When according to colposcopy and biopsy results, an excisional treatment of a cervical precancer lesion is needed, the histology of the excised tissue will complete the end point of the study. The colposcopy and histological findings will be used as the gold standard if biopsies are taken.

In case of normal satisfactory colposcopic findings without biopsy taking, colposcopy will provide the study outcome.

Three new PCR-based HPV 'in vitro diagnostic devices' (Papilloplex, HPV Oncopredict RNA, HPV Oncopredict DNA) developed as part of the SME Instrument Project 'HPV OncoPredict (GA-806551)' will be assessed.

Being tested
Self-Collecting Devices, In Vitro Diagnostic Assays
Keywords
self-sampling, HPV testing, Diagnostic Test Accuracy, Cervical Intraepithelial Neoplasia, Urine, Cervical Cancer Screening
Medical subject headings
Uterine Cervical Neoplasms, Carcinoma in Situ, Neoplasms, Neoplasms by Histologic Type, Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-Collecting DevicesDevice

    FLOQSwab (Copan) Colli-Pee (Novosanis)

  • In Vitro Diagnostic AssaysDiagnostic test

    Papilloplex (GeneFirst) HPV Oncopredict DNA (Hiantis) HPV Oncopredict RNA (GeneFirst)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative accuracy urine vs clinician-collected samples

    Relative sensitivity and specificity of each hrHPV DNA assay for detection of cervical intraepithelial neoplasia of grade II or worse (CIN2+) on urine vs on clinician-collected samples.

    Measured: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.

  2. Relative accuracy self-collected vaginal vs clinician-collected samples

    Relative sensitivity and specificity of each hrHPV DNA assay for detection of cervical intraepithelial neoplasia of grade II or worse (CIN2+) on self-collected vaginal vs on clinician-collected samples.

    Measured: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.

Secondary outcomes (8)

  1. Absolute accuracy for each sample type

    Absolute clinical sensitivity and specificity for finding underlying CIN2/3+ of the investigated hrHPV assays applied on each sample.

    Measured: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.

  2. Absolute accuracy among hrHPV DNA-positive women

    Absolute clinical sensitivity and specificity using HPV OncoPredict RNA among women with hrHPV DNA-positive result on one of the self-samples.

    Measured: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.

  3. Concordance of presence or absence of HPV genotypes between different sample types

    Concordance of presence of hrHPV and of HPV genotypes between urine, vaginal and clinician-collected samples.

    Measured: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.

  4. Correlation viral load signals between different sample types

    Correlation of genotype-specific viral load signals between urine, vaginal and clinician-collected samples.

    Measured: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.

  5. Concordance of presence or absence of internal control gene between different sample types

    Concordance of positivity for the human cellular control between urine, vaginal and clinician-collected samples.

    Measured: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.

  6. Correlation internal control gene signals between different sample types

    Correlation of signals for the human internal control gene between urine, vaginal and clinician-collected samples.

    Measured: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.

  7. Positivity rates human control gene

    Positivity rates for human cellular control in the different sample types.

    Measured: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.

  8. Questionnaire for the acceptance of self-collection

    Women's acceptance and preference regarding urine collection, vaginal self-sampling or collection by a clinician will be assessed through a questionnaire.

    Measured: One day, at the day of colposcopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2020
  2. Study start16 Jul 2020
  3. Primary completion23 Feb 2022
  4. Study completion15 Mar 2022

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
600 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT04312737
Sponsor's protocol ID
WP6-HPVONC
Other IDs
GA-806551
Acronym
EU-VALHUDES
Status last verified
Jan 2023
First submitted
11 Mar 2020
Last updated
6 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Arbyn M, Peeters E, Benoy I, Vanden Broeck D, Bogers J, De Sutter P, Donders G, Tjalma W, Weyers S, Cuschieri K, Poljak M, Bonde J, Cocuzza C, Zhao FH, Van Keer S, Vorsters A. VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples. J Clin Virol. 2018 Oct;107:52-56. doi: 10.1016/j.jcv.2018.08.006. Epub 2018 Aug 22.

    PubMed 30195193

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Intraepithelial Neoplasia Grade 2/3 and Neoplasm Cervix, run by Hiantis Srl at 6 sites in 3 countries.

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 6 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 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy, Ireland, United Kingdom. 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?

Relative accuracy urine vs clinician-collected samples (time frame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04312737, which also lists 1 linked publication.

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 6 Jan 2023.

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