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Self-collected Vaginal and Urine Samples in HIV-positive Women

NCT05783167CompletedOBSERVATIONAL

Summary

This study assesses topics as Human Immunodeficiency Virus (HIV), Human Papilloma Virus (HPV), and cancer screening methods. The focus will be on evaluating feasibility of implementing novel cancer screening modalities in a low-resource setting in Guinea-Bissau and further to estimate the prevalence of the precancerous virus HPV amongst women living with HIV. In the study the investigators will collect urinary and vaginal self-samples for HPV testing, and further evaluate the feasibility of implementing the devices as screening modalities through questionnaires given to the women.

Key Facts

Lead Sponsor

University of Aarhus

Enrollment

502

Start Date

2023-05-29

Completion Date

2023-11-23

Study Type

OBSERVATIONAL

Official Title

Self-collected Cervical Cancer Screening Samples for Detection of Human Papillomavirus in HIV-positive Women - a Pilot Study of Self-collected Vaginal and Urine Samples

Interventions

Self-sampling for HPV infection

Conditions

HIV InfectionsHPV-Related Cervical CarcinomaCervical CancerCoinfectionHIV

Eligibility

Age Range

18 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

* HIV-positive (women with HIV-1, HIV-2 AND HIV1/2 are all eligible)
* Age between 18 and 65 years

Exclusion Criteria:

* Current pregnancy
* Pregnancy within the last 3 months
* Prior hysterectomy
* Women using other vaginal products than contraceptives and water based lubricants
* Women who don't understand the extent of the study
* Bleeding due to ongoing period

Outcome Measures

Primary Outcomes

Feasibility of implementing HPV self sampling for cervical cancer screening

Among women meeting the inclusion criteria, the investigators want to estimate the prevalence of how many accepts the offer to collect self-samples, thereby gaining knowledge on the feasibility of implementing self-sampling as a cervical cancer screening method in Guinea-Bissau.

Time frame: April 2023 - February 2024

HPV-prevalence among HIV-infected women in Guinea-Bissau

The investigators want to estimate the prevalence of high risk HPV infection among HIV-infected women in the Nationwide HIV-cohort in Guinea-Bissau.

Time frame: April 2023 - February 2024

Secondary Outcomes

Experiences with self-collected vaginal and urine samples

Among the women accepting the invitation to enroll in the study, the investigators will through a questionnaire obtain data on the participants experiences with the two self-sampling devices.

Time frame: April 2023 - February 2024

HPV-genotype agreement between vaginal- and urine samples

Among HPV-positive women the investigators want to describe the genotype agreement among the two sample types

Time frame: April 2023 - February 2024

Locations

Centro Tratamento Ambúlatorios na Guinea-Bissau, Bissau, Guinea-Bissau

Linked Papers

2022-08-24

Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: A diagnostic test accuracy study

Urine collection is a non-invasive self-sampling method offering the prospect of reaching women un(der)-screened for cervical cancer. The VALHUDES research framework was designed to address the lack of clinical accuracy data for high-risk (hr)HPV testing using urine samples. Here, we report on the analytical and clinical accuracy of hrHPV testing on first-void urine, collected at home, using an extended HPV genotyping assay. Paired first-void urine (Colli-Pee with UCM, Novosanis; index test) and clinician-collected cervical samples (Cervex-Brush, Rovers in PreservCyt Solution, Hologic; comparator test) were collected from 492 women aged 19 to 72 years attending colposcopy (reference test, with histology if indicated) (VALHUDES; NCT03064087). Extended HPV genotyping was performed on paired samples with the BD Onclarity HPV Assay. Cut-offs defined for cervical samples were also applied for first-void urine. HrHPV testing in first-void urine was similarly sensitive for both CIN2+ (ratio 1.00; 95% CI: 0.93-1.07) and CIN3 (ratio 0.98; 95% CI: 0.88-1.08), and marginally less specific for <CIN2 (ratio 0.92; 95% CI: 0.84-0.996) compared to cervical samples. HPV test agreement between sample pairs expressed as Cohen's Kappa (κ) was moderate to excellent for overall hrHPV and individual genotypes (or groups) (κ=0.56-0.85). BD Onclarity HPV Assay on first-void urine has similar clinical sensitivity and somewhat lower specificity to detect cervical precancer to testing on clinician-collected cervical samples.

2020-12-04

Urine collection in cervical cancer screening – analytical comparison of two HPV DNA assays

Abstract Background To reach non-participants, reluctant to undergo clinician-based cervical cancer screening and vaginal self-sampling, urine collection for high-risk human papillomavirus detection (hrHPV) may be valuable. Using two hrHPV DNA assays, we evaluated the concordance of hrHPV positivity in urine samples in comparison with vaginal self-samples and cervical cytology samples taken by the general practitioner (GP). We also studied women’s acceptance of urine collection and preferences towards the different sampling procedures. Methods One hundred fifty paired self-collected urine and vaginal samples and GP-collected cervical cytology samples were obtained from 30 to 59-year-old women diagnosed with ASC-US within the Danish cervical cancer screening program. After undergoing cervical cytology at the GP, the women collected first-void urine and vaginal samples at home and completed a questionnaire. Each sample was hrHPV DNA tested by the GENOMICA CLART® and COBAS® 4800 assays. Concordance in hrHPV detection between sample types was determined using Kappa ( k ) statistics. Sensitivity and specificity of hrHPV detection in urine was calculated using cervical sampling as reference. Results With the COBAS assay, urine showed good concordance to the vaginal ( k = 0.66) self-samples and cervical samples ( k = 0.66) for hrHPV detection. The corresponding concordance was moderate ( k = 0.59 and k = 0.47) using CLART. Compared to cervical sampling, urinary hrHPV detection had a sensitivity of 63.9% and a specificity of 96.5% using COBAS; compared with 51.6 and 92.4% for CLART. Invalid hrHPV test rates were 1.8% for COBAS and 26.9% for CLART. Urine collection was well-accepted and 42.3% of the women ranked it as the most preferred future screening procedure. Conclusions Urine collection provides a well-accepted screening option. With COBAS, higher concordance between urine and vaginal self-sampling and cervical sampling for hrHPV detection was found compared to CLART. Urinary hrHPV detection with COBAS is feasible, but its accuracy may need to be improved before urine collection at home can be offered to non-participants reluctant to both cervical sampling and vaginal self-sampling.

Linked Investigators

Berit Andersen

Bodil Hammer Bech

Jørgen Skov Jensen

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.

Severien Van Keer