Urinary and Vaginal HPV Testing in Cervical Cancer Screening

Uterine Cervical Neoplasms Clinical Trial

Official title:

Urinary and Vaginal HPV Testing as a Novel Cervical Cancer Screening Tool: a Diagnostic Test Accuracy Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05065853
• Other study ID #: 2703
• Status: Not yet recruiting
• Start date: October 18, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2021
• Source: University of Aarhus
• Contact: mette tranberg, post doc
• Phone: +45 7842 0264
• Email: mettrani[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cervical cancer, caused by high-risk human papillomavirus (HPV) infection, poses a problem worldwide as it is the fourth most common female cancer. Fifty percent of all invasive cervical cancers occur among the 25% not attending cervical cancer screening. To reach these women, this project will contribute to the development of a novel and accurate urinary and vaginal screening tool, which allows women to collect the screening samples at home. This project tests the hypotheses: 1) urinary HPV testing is non-inferior to HPV testing on clinician-collected cervical samples for detection of high-grade cervical pre-cancer, 2) Vaginal HPV testing is non-inferior to HPV testing on clinician-collected cervical samples for detection of high-grade cervical pre-cancer and 3) DNA methylation testing is suitable as a colposcopy triage test among women with HPV-positive urine and/or vaginal samples to prevent unnecessary colposcopies and overtreatment of women without clinically meaningful HPV infections. If confirmed, urinary and vaginal HPV testing could revolutionize todays screening programs and keep Denmark at the forefront of cervical cancer prevention.

Description:

Paired urine, vaginal, and clinician-collected cervical samples will be obtained from approximately 330 women aged 23-64 years referred for colposcopy and cervical biopsies due to abnormal screening result or referred for cervical excision due to treatment of CIN2+. Upon informed consent, the women will collect a first-void urine sample and a vaginal self-sample. Before colposcopy or excision, a clinician will collect a cervical sample. Among women referred for colposcopy, four cervical punch biopsies will be taken. For women referred for excision, a cone biopsy will be taken using a loop electrosurgical excision procedure. Upon arrival in the laboratory, the paired urine, vaginal and cervical samples will be HPV tested using the Cobas 4800 HPV DNA assay. Histological results will served as reference and be grouped as ≤CIN1 (normal tissue, CIN1) versus CIN2+. The performance of the six individual methylation markers and combinations thereof will be evaluated using the histological results as reference.

The primary endpoint will be the relative sensitivity and specificity of HPV testing in first-void urine, vaginal self-sample versus clinician-collected cervical samples to detect CIN2+. Non-inferiority of HPV testing between sample types will be evaluated against a margin of 90% for sensitivity and 98% for specificity. The performance of each methylation marker will be illustrated by ROC curves and assessed by the area under the curve.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 23 Years to 64 Years

Eligibility

Inclusion Criteria:

• Females

• Aged 23-64 years

• Referred for colposcopy and cervical biopsies or referred for cervical excision

Exclusion Criteria:

• younger than 23 years

• older than 64 years

• not provided informed conte

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• urine self-sampling group
collection of urine and vaginal samples
• clinician-collected cervical sample group
A clinician takes a smear from cervix according to standard routine

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of Aarhus	Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium, Departement of Pathology, Randers Regional Hospital , Denmark, Department of Gynecology, Randers Regional Hospital, Denmark, University Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative sensitivity and specificity of urinary sampling	The primary endpoint will be the relative sensitivity and specificity of HPV testing in first-void urine versus clinician-collected cervical samples to detect CIN2+	at baseline
Primary	relative sensitivity and specificity of vaginal self-sampling	The primary endpoint will be the relative sensitivity and specificity of HPV testing in vaginal self-samples versus clinician-collected cervical samples to detect CIN2+	at baseline