Uterine Cervical NeoplasmsNCT05065853
Urinary and Vaginal HPV Testing in Cervical Cancer Screening
An observational study of Uterine Cervical Neoplasms, run by University of Aarhus.
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. Read more about this study
- Who is it for?
- Ages 23 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- urine self-sampling group and clinician-collected cervical sample group
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 18 Oct 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women aged 23-64 years referred for colposcopy and cervical biopsies due to abnormal cervical cancer screening result or referred for cervical excision due to treatment of CIN2+
Who may be able to join
- Females
- Aged 23-64 years
- Referred for colposcopy and cervical biopsies or referred for cervical excision
Who cannot join
- younger than 23 years
- older than 64 years
- not provided informed conte
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Urinary and Vaginal HPV Testing as a Novel Cervical Cancer Screening Tool: a Diagnostic Test Accuracy Study
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.
Read the 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
- Being tested
- urine self-sampling group, clinician-collected cervical sample group
- Keywords
- HPV DNA tests, self-collection, cervical cancer screening
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine self-sampling groupDiagnostic test
Also called vaginal self-sampling group
collection of urine and vaginal samples
clinician-collected cervical sample groupDiagnostic test
A clinician takes a smear from cervix according to standard routine
What is being measured
The primary outcome is the main question the study is designed to answer.
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+
Measured: at baseline
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+
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start18 Oct 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital, Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium
- Responsible party
- Principal investigator, Mette Tranberg Nielsen, University of Aarhus
- Investigators
- Mette Tranberg, post doc, Principal investigator, Randers Regional Hospital and Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065853
- Sponsor's protocol ID
- 2703
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tranberg M, Van Keer S, Hesselink AT, Norgaard P, Brondum R, Wu C, Gustafson LW, Hammer A, Bor P, Binderup KO, Blach C, Vorsters A, Steenbergen R. Evaluating DNA methylation markers and extended HPV genotyping in first-void urine for detecting high-grade cervical lesions in HPV-positive women: a cross-sectional study. BMC Med. 2026 Apr 10;24(1):308. doi: 10.1186/s12916-026-04837-5.
PubMed 41957618Tranberg 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.
PubMed 40457337
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary and Vaginal HPV Testing as a Novel Cervical Cancer Screening Tool: a Diagnostic Test Accuracy Study
- ClinicalTrials.gov ID
- NCT05065853
- Acronym / sponsor ID
- 2703
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- HPV DNA tests, self-collection, cervical cancer screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Randers Regional Hospital, Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium
- Study start
- 18 Oct 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 23 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women aged 23-64 years referred for colposcopy and cervical biopsies due to abnormal cervical cancer screening result or referred for cervical excision due to treatment of CIN2+
Key inclusion criteria (3 listed)
- Females
- Aged 23-64 years
- Referred for colposcopy and cervical biopsies or referred for cervical excision
Key exclusion criteria (3 listed)
- younger than 23 years
- older than 64 years
- not provided informed conte
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine self-sampling groupAlso: vaginal self-sampling groupcollection of urine and vaginal samples | Diagnostic test | – |
| clinician-collected cervical sample groupA clinician takes a smear from cervix according to standard routine | Diagnostic test | – |
Primary outcome
relative sensitivity and specificity of urinary sampling
Time frame: at baseline
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+
relative sensitivity and specificity of vaginal self-sampling
Time frame: at baseline
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+
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Derived from this study: PubMed 41957618Tranberg M, Van Keer S, Hesselink AT, Norgaard P, Brondum R, Wu C, Gustafson LW, Hammer A, Bor P, Binderup KO, Blach C, Vorsters A, Steenbergen R. Evaluating DNA methylation markers and extended HPV genotyping in first-void urine for detecting high-grade cervical lesions in HPV-positive women: a cross-sectional study. BMC Med. 2026 Apr 10;24(1):308. doi: 10.1186/s12916-026-04837-5.
- Derived from this study: PubMed 40457337Tranberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Tranberg, post doc principal investigator
Randers Regional Hospital and Aarhus University
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Neoplasms, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mette tranberg, post doc (+45 7842 0264, mettrani@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative sensitivity and specificity of urinary sampling (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05065853, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.