NCT04312737

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 16, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

1.6 years

First QC Date

March 11, 2020

Last Update Submit

January 5, 2023

Conditions

Cervical Intraepithelial Neoplasia Grade 2/3Neoplasm CervixCarcinoma in SituCarcinoma Cervix UterineNeoplasmsNeoplasms by Histologic Type

Keywords

self-samplingHPV testingDiagnostic Test AccuracyCervical Intraepithelial NeoplasiaUrineCervical Cancer Screening

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    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 Outcomes (8)

  • Absolute accuracy for each sample type

    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

    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

    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

    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

    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 more secondary outcomes

Interventions

Self-Collecting DevicesDEVICE

FLOQSwab (Copan) Colli-Pee (Novosanis)

In Vitro Diagnostic AssaysDIAGNOSTIC_TEST

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

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The Coombe Women and Infants University Hospital, & Trinity College

Dublin, Ireland

Location

Dipartimento di Chirurgia e Medicina - Università Milano-Bicocca

Monza, Monza Brianza, Italy

Location

Spedali Civili di Brescia

Brescia, Italy

Location

European Institute of Oncology

Milan, Italy

Location

ATS-Sardegna Azienda Tutela Salute. ASSL Sassari

Sassari, Italy

Location

Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 30195193RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Urine, vaginal and cervical samples

MeSH Terms

Conditions

Uterine Cervical NeoplasmsCarcinoma in SituNeoplasmsNeoplasms by Histologic TypeUterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialPrecancerous Conditions

Study Officials

  • Marc Arbyn, Dr

    Sciensano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 18, 2020

Study Start

July 16, 2020

Primary Completion

February 23, 2022

Study Completion

March 15, 2022

Last Updated

January 6, 2023

Record last verified: 2023-01

Locations

IT(4)IE(1)GB(1)