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

Hiantis

Status: Completed

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

Treatments: Diagnostic Test: In Vitro Diagnostic Assays; Device: Self-Collecting Devices

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04312737

GA-806551 (Other Grant/Funding Number)

WP6-HPVONC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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