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.
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.
Study Type
OBSERVATIONAL
Enrollment
600
FLOQSwab (Copan) Colli-Pee (Novosanis)
Papilloplex (GeneFirst) HPV Oncopredict DNA (Hiantis) HPV Oncopredict RNA (GeneFirst)
The Coombe Women and Infants University Hospital, & Trinity College
Dublin, Ireland
Dipartimento di Chirurgia e Medicina - Università Milano-Bicocca
Monza, Monza Brianza, Italy
Spedali Civili di Brescia
Brescia, Italy
European Institute of Oncology
Milan, Italy
ATS-Sardegna Azienda Tutela Salute. ASSL Sassari
Sassari, Italy
Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
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.
Time frame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
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.
Time frame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
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.
Time frame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
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.
Time frame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
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.
Time frame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
Correlation viral load signals between different sample types
Correlation of genotype-specific viral load signals between urine, vaginal and clinician-collected samples.
Time frame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
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.
Time frame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
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.
Time frame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
Positivity rates human control gene
Positivity rates for human cellular control in the different sample types.
Time frame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
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.
Time frame: One day, at the day of colposcopy
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