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

Neoplasms Clinical Trial

— EU-VALHUDES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312737
• Other study ID #: WP6-HPVONC
• Secondary ID: GA-806551
• Status: Completed
• Start date: July 16, 2020
• Est. completion date: March 15, 2022

Study information

• Verified date: January 2023
• Source: Hiantis Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 15, 2022
• Est. primary completion date: February 23, 2022
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
Ireland	The Coombe Women and Infants University Hospital, & Trinity College	Dublin
Italy	Spedali Civili di Brescia	Brescia
Italy	European Institute of Oncology	Milan
Italy	Dipartimento di Chirurgia e Medicina - Università Milano-Bicocca	Monza	Monza Brianza
Italy	ATS-Sardegna Azienda Tutela Salute. ASSL Sassari	Sassari
United Kingdom	Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh	Edinburgh

Sponsors (3)

Lead Sponsor	Collaborator
Hiantis Srl	Genefirst LTD, Sciensano

Countries where clinical trial is conducted

Ireland,  Italy,  United Kingdom, 

References & 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 collecti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Absolute accuracy for each sample type	Absolute clinical sensitivity and specificity for finding underlying CIN2/3+ of the investigated hrHPV assays applied on each sample.	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	Absolute accuracy among hrHPV DNA-positive women	Absolute clinical sensitivity and specificity using HPV OncoPredict RNA among women with hrHPV DNA-positive result on one of the self-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	Concordance of presence or absence of HPV genotypes between different sample types	Concordance of presence of hrHPV and of HPV genotypes between urine, vaginal 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	Correlation viral load signals between different sample types	Correlation of genotype-specific viral load signals between urine, vaginal 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	Concordance of presence or absence of internal control gene between different sample types	Concordance of positivity for the human cellular control between urine, vaginal 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	Correlation internal control gene signals between different sample types	Correlation of signals for the human internal control gene between urine, vaginal 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	Positivity rates human control gene	Positivity rates for human cellular control in the 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.
Secondary	Questionnaire for the acceptance of self-collection	Women's acceptance and preference regarding urine collection, vaginal self-sampling or collection by a clinician will be assessed through a questionnaire.	One day, at the day of colposcopy