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

January 5, 2023 updated by: Hiantis Srl

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • The Coombe Women and Infants University Hospital, & Trinity College
  • Italy
      • Brescia, Italy
        • Spedali Civili di Brescia
      • Milan, Italy
        • European Institute of Oncology
      • Sassari, Italy
        • ATS-Sardegna Azienda Tutela Salute. ASSL Sassari
    • Monza Brianza
      • Monza, Monza Brianza, Italy
        • Dipartimento di Chirurgia e Medicina - Università Milano-Bicocca
  • United Kingdom
      • Edinburgh, United Kingdom
        • Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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]

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
Relative accuracy self-collected vaginal 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.
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute accuracy for each sample type
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.
Absolute clinical sensitivity and specificity for finding underlying CIN2/3+ of the investigated hrHPV assays applied on each sample.
One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
Absolute accuracy among hrHPV DNA-positive women
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.
Absolute clinical sensitivity and specificity using HPV OncoPredict RNA among women with hrHPV DNA-positive result on one of the self-samples.
One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
Concordance of presence or absence of HPV genotypes between different sample types
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.
Concordance of presence of hrHPV and of HPV genotypes between urine, vaginal and clinician-collected samples.
One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
Correlation viral load signals between different sample types
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.
Correlation of genotype-specific viral load signals between urine, vaginal and clinician-collected samples.
One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
Concordance of presence or absence of internal control gene between different sample types
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.
Concordance of positivity for the human cellular control between urine, vaginal and clinician-collected samples.
One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
Correlation internal control gene signals between different sample types
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.
Correlation of signals for the human internal control gene between urine, vaginal and clinician-collected samples.
One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
Positivity rates human control gene
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.
Positivity rates for human cellular control in the different sample types.
One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
Questionnaire for the acceptance of self-collection
Time Frame: One day, at the day of colposcopy
Women's acceptance and preference regarding urine collection, vaginal self-sampling or collection by a clinician will be assessed through a questionnaire.
One day, at the day of colposcopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hiantis Srl

Collaborators

Sciensano
Genefirst LTD

Investigators

  • Principal Investigator: Marc Arbyn, Dr, Sciensano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2020

Primary Completion (Actual)

February 23, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WP6-HPVONC
  • GA-806551 (Other Grant/Funding Number: Horizon 2020 SME Instrument Project)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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