Urinary and Vaginal HPV Testing in Cervical Cancer Screening

NCT ID: NCT05065853

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2023-12-31

Brief 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.

Detailed 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.

Conditions

Uterine Cervical Neoplasms

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

urine self-sampling group

collection of urine and vaginal samples

Intervention Type: DIAGNOSTIC_TEST

clinician-collected cervical sample group

A clinician takes a smear from cervix according to standard routine

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

vaginal self-sampling group

Eligibility Criteria

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

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital, Denmark

UNKNOWN

Sponsor Role: collaborator

Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium

UNKNOWN

Sponsor Role: collaborator

Department of Gynecology, Randers Regional Hospital, Denmark

UNKNOWN

Sponsor Role: collaborator

Departement of Pathology, Randers Regional Hospital , Denmark

UNKNOWN

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Mette Tranberg Nielsen

post doc, PhD, MScH, biomedical laboratory scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mette Tranberg, post doc

Role: PRINCIPAL_INVESTIGATOR

Randers Regional Hospital and Aarhus University

Central Contacts

mette tranberg, post doc

Role: CONTACT

mettrani@rm.dk

+45 7842 0264

Berit Andersen, prof. MD

Role: CONTACT

berand@rm.dk

+45 7842 0171

References

Tranberg M, Van Keer S, Jensen JS, Norgaard P, Gustafson LW, Hammer A, Bor P, Binderup KO, Blach C, Vorsters A. High-risk human papillomavirus testing in first-void urine as a novel and non-invasive cervical cancer screening modality-a Danish diagnostic test accuracy study. BMC Med. 2025 Jun 2;23(1):327. doi: 10.1186/s12916-025-04149-0.

Reference Type: DERIVED

PMID: 40457337 (View on PubMed)

Other Identifiers

2703

Identifier Type: -

Identifier Source: org_study_id