Clinical trial NCT04312737: Evaluation of in Vitro Devices on Self-collected Vaginal Swab and Urine Sample for Testing of Human Papilloma Virus
Official title: European VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and Urine Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Intraepithelial Neoplasia Grade 2/3
Neoplasm Cervix
Carcinoma in Situ
Carcinoma Cervix Uterine
Neoplasms
Neoplasms by Histologic Type
Keywords: self-sampling
HPV testing
Diagnostic Test Accuracy
Cervical Intraepithelial Neoplasia
Urine
Cervical Cancer Screening
Lead sponsor: Hiantis Srl
Sponsor class: INDUSTRY
Collaborators: name: Genefirst LTD
name: Sciensano
First posted: 2020-03-18
Enrollment: 600
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women referred to colposcopy evaluation for any reason \[i.e. previous history of abnormal cervical screen test results (cytology, HPV test), previous abnormal colposcopy\]

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative accuracy urine vs clinician-collected samples
timeFrame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
measure: Relative accuracy self-collected vaginal vs clinician-collected samples
timeFrame: 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:
measure: Absolute accuracy for each sample type
timeFrame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
measure: Absolute accuracy among hrHPV DNA-positive women
timeFrame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
measure: Concordance of presence or absence of HPV genotypes between different sample types
timeFrame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
measure: Correlation viral load signals between different sample types
timeFrame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
measure: Concordance of presence or absence of internal control gene between different sample types
timeFrame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
measure: Correlation internal control gene signals between different sample types
timeFrame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
measure: Positivity rates human control gene
timeFrame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
measure: Questionnaire for the acceptance of self-collection
timeFrame: One day, at the day of colposcopy
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: The Coombe Women and Infants University Hospital, & Trinity College
city: Monza
country: Italy
facility: Dipartimento di Chirurgia e Medicina - Università Milano-Bicocca
state: Monza Brianza
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Milan
country: Italy
facility: European Institute of Oncology
city: Sassari
country: Italy
facility: ATS-Sardegna Azienda Tutela Salute. ASSL Sassari
city: Edinburgh
country: United Kingdom
facility: Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh
Study officials:
affiliation: Sciensano
name: Marc Arbyn, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.