Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples (Ext-VALHUDES)

April 26, 2021 updated by: Clementina Cocuzza, University of Milano Bicocca

Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and First-void Urine Samples

The "Extended VALHUDES" study is a Clinical Performance / Diagnostic Test Accuracy Study that aims to extend validation, achieved as part of the "Belgian VALHUDES", of HPV testing using BD Onclarity on samples collected using Copan's devices for dry self-sampling of vaginal material and for first-void urine: FLOQSwab® 5E089N and UriSponge™.

Study Overview

Status

Recruiting

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 UriSponge™ 8E031S100 device) and a vaginal sample (with FLOQSwab® 5E089N device), prior to undergoing colposcopy. Just before colposcopic examination, a clinician will also collect a cervical sample using a Cervex-Brush.

A colposcopy-targeted biopsy or histology following excisional treatment of a cervical precancer lesion will be undertaken if appropriate. The colposcopy and/or histological findings will be used as the gold standard. In case of normal satisfactory colposcopic findings without biopsy taking, colposcopy will provide the study outcome.

Virological accuracy of HPV testing using: [a] BD Onclarity on FLOQSwab® 5E089N vaginal self-samples, [b] BD Onclarity on UriSponge™ 8E031S100 urine specimens, will be compared to BD Onclarity testing on a cervical samples collected by a clinician.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20141
      • Sassari, Italy, 07100

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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with a recent history of abnormal Pap smear who are referred to colposcopy in one of the 2 Italian Colposcopy Centres:

  • Istituto Europeo di Oncolgia (IEO), Milan
  • Coordinamento Consultori Familiari, ATS Sardegna

Description

Inclusion Criteria:

  • Women, referred to colposcopy due to abnormal Pap-test result, who agree to participate in the study by signing an informed consent form

Exclusion Criteria:

  • Women younger than 25 or older than 64 years of age
  • Hysterectomized women
  • Women with known pregnancy
  • Non-consenting women
  • Women that are not able to understand and/or sign the informed consent.

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: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women referred to colposcopy
Three sample types (urine, vaginal and cervical) will be collected from all enrolled women.
Diagnostic test: BD Onclarity™ HPV assay
Women will be asked to self-collect first-void urine using Copan's UriSponge™ 8E031S100 and vaginal swabs using Copan's FLOQSwabs® 5E089N. All samples will be tested with BD Onclarity™ HPV assay. HPV test results on self-collected samples will be compared to those obtained when testing clinician-collected cervical sample
Other Names:
  • Copan's FLOQSwabs® 5E089N
  • Copan's UriSponge™ 8E031S100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analytical performance and Clinical accuracy
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 the presence of HPV and of the partial and extended HPV genotyping results applied on self- 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Women's Acceptance and Preferences regarding urine collection, vaginal self-sampling or cervical sample collection by a clinician.
Time Frame: One day
Acceptance and preferences regarding urine collection, vaginal self-sampling or clinicians' collected cervical samples will be assessed through a questionnaire administered to participating women at the time of colposcopy. The questionnaire will allow to determine the percentage of women expressing a preference for urine collection and/or vaginal self-sampling over clinicians' collected cervical samples.
One day

Collaborators and Investigators

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

Sponsor

University of Milano Bicocca

Collaborators

Becton, Dickinson and Company
Università degli Studi di Sassari
Sciensano
Istituto Europeo di Oncologia
COPAN ITALIA SPA
ATS Sardegna

Investigators

  • Principal Investigator: Clementina E. Cocuzza, MD, PhD, School of Medicine and Surgery, University of Milano-Bicocca

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)

March 8, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 6, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMilanoBicocca&BD/Copan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Study protocol and results will be published at a later date

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.

Yes

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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