Neoplasms Clinical Trial
— EU-VALHUDESOfficial title:
European VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and Urine Samples
Verified date | January 2023 |
Source | Hiantis Srl |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | March 15, 2022 |
Est. primary completion date | February 23, 2022 |
Accepts healthy volunteers | |
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Hiantis Srl | Genefirst LTD, Sciensano |
Ireland, Italy, United Kingdom,
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
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 |
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