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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-16

Study Completion Date

2022-03-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Self-Collecting Devices

FLOQSwab (Copan) Colli-Pee (Novosanis)

Intervention Type DEVICE

In Vitro Diagnostic Assays

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No