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Urinary and Vaginal HPV Testing in Cervical Cancer Screening

NCT05065853UNKNOWNOBSERVATIONAL

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.

Key Facts

Lead Sponsor

University of Aarhus

Enrollment

330

Start Date

2021-10-18

Completion Date

2023-12-31

Study Type

OBSERVATIONAL

Official Title

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

Interventions

urine self-sampling groupclinician-collected cervical sample group

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

23 Years – 64 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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+

Time frame: 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+

Time frame: at baseline

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.

Linked Papers

2025-06-02

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

First-void urine (FVU) collection for high-risk human papillomavirus (hrHPV) testing has game-changing potential to improve cervical cancer prevention among under-screened women who remain unreached by clinician-based cervical cancer screening and vaginal self-sampling. Yet, the wide variation in the clinical accuracy of hrHPV testing in urine for detecting high-grade cervical intraepithelial neoplasia (CIN2 + /CIN3 +) across studies and clinical settings highlights the importance of local piloting and validation. This study determined the relative clinical accuracy of hrHPV testing in FVU versus clinician-collected cervical samples to detect CIN2 + /CIN3 + in a Danish referral population. In a diagnostic test accuracy study, paired FVU (10 mL Colli-Pee device; index test) and cervical samples (Cervex Combi brush; comparator test) were obtained from 325 women aged 23-64 years (median age 36.0 years (IQR 29-46) who were either referred for colposcopy and biopsy taking or a cervical excision (reference test; available for all participants). Samples were tested using Allplex HR HPV DNA extended genotyping assay. Same absolute cut-off for hrHPV positivity applied for cervical samples was used for FVU. Of the 325 women, 145 (44.6%), 180 (55.4%), and 138 (42.5%) were diagnosed with < CIN2, CIN2 + , and CIN3 + , respectively. Sensitivity to detect CIN2 + (ratio 0.97, 95% CI 0.92-1.02, p This is the first study proving similar CIN2 + /CIN3 + sensitivity for FVU-hrHPV testing using the 10-mL Colli-Pee device and Allplex HR HPV assay compared to testing in cervical samples. From an implementation perspective, further research is needed to gather additional clinical accuracy and acceptability data on hrHPV testing of FVU-device collection in under-screened populations to support its broader integration into screening programmes. Clinicaltrials.gov: NCT05065853.

Linked Investigators

Mette Tranberg

I am an intervention and epidemiological researcher with powerful laboratory skills enabling me to conduct large-scale population-based intervention studies combining the worlds of epidemiology, cervical cancer screening, and diagnostics into one.