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

Sponsor

Hiantis Srl (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04312737

Collaborator

Genefirst LTD (Other), Sciensano (Other)

600

Enrollment

Location

17.5

Anticipated Duration (Months)

34.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Intraepithelial Neoplasia Grade 2/3 Neoplasm Cervix Carcinoma in Situ Carcinoma Cervix Uterine Neoplasms Neoplasms by Histologic Type	Device: Self-Collecting Devices Diagnostic Test: In Vitro Diagnostic Assays

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

600 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jul 16, 2020

Anticipated Primary Completion Date :

Dec 23, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

Relative accuracy urine vs 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.]
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.
Relative accuracy self-collected vaginal vs 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.]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

Female

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