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

NCT04312737 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2023-01-06

No results posted yet for this study

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.

Conditions

  • Cervical Intraepithelial Neoplasia Grade 2/3
  • Neoplasm Cervix
  • Carcinoma in Situ
  • Carcinoma Cervix Uterine
  • Neoplasms
  • Neoplasms by Histologic Type

Interventions

DEVICE

Self-Collecting Devices

FLOQSwab (Copan) Colli-Pee (Novosanis)

DIAGNOSTIC_TEST

In Vitro Diagnostic Assays

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

Sponsors & Collaborators

  • Genefirst LTD

    collaborator UNKNOWN

  • Sciensano

    collaborator OTHER_GOV

  • Hiantis Srl

    lead INDUSTRY

Principal Investigators

  • Marc Arbyn, Dr · Sciensano

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-16
Primary Completion
2022-02-23
Completion
2022-03-15
FDA Device
Yes

Countries

  • Ireland
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04312737 on ClinicalTrials.gov