Where does OCRA's clinical trial data come from?

OCRA indexes clinical trials from ClinicalTrials.gov, the official U.S. registry maintained by the National Library of Medicine. Trials are matched to diseases, investigators, and funded research tracked across the platform.

How do I find clinical trials for ovarian cancer?

Search by condition, treatment type, trial phase, or NCT identifier. Each trial page shows current status, eligibility criteria, study locations, and a direct link to the ClinicalTrials.gov source record.

How often is clinical trial data updated?

Trial data is refreshed through periodic ingestion from the ClinicalTrials.gov v2 API. Status changes, new enrollments, and newly registered trials are captured during each update cycle.

HPV Testing In Polish POpulation-based Cervical Cancer Screening Program.

NCT04111835CompletedNAINTERVENTIONAL

Summary

The HIPPO PROJECT is a randomized healthcare study nested in the OCCSP in Poland. This project will assess the performance of the new screening test (HR HPV test) before its implementation in Poland.

Key Facts

Lead Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Enrollment

33000

Start Date

2019-10-28

Completion Date

2022-11-03

Study Type

INTERVENTIONAL

Official Title

HPV Testing In Polish POpulation-based Cervical Cancer Screening Program - a Randomized Healthcare Policy Trial

Interventions

Offering an alternative cervical cancer screening method - hrHPV molecular testing.

Conditions

Cervical Cancer

Eligibility

Age Range

30 Years – 59 Years

Sex

FEMALE

Inclusion Criteria:

-women aged 30-59 with no screening Pap test within the preceding three years in the OCCSP and women with risk factors entitled to annual screening based on information from the SIMP and not tested within preceding 12 months (based on information from the screening database SIMP)

Exclusion Criteria:

-women with screening Pap test within the preceding three years in the OCCSP

Outcome Measures

Primary Outcomes

Detection rate of histologically confirmed CIN2 or worse in each screening arm

Time frame: 12 months after the date of the positive screening test

Detection rate ratio of CIN2+ in HPV test vs cytology arm (and detection rate ratios between the hrHPV test and cytology)

This is defined as: number of women with CIN2+ detected in the HPV arm/women screened by HPV ........................................................................................................................... number of women with CIN2+ detected in the cytology arm/women screened in with cytology

Time frame: 12 months after the date of the positive screening test

Secondary Outcomes

Detection rate ratio of CIN1+, CIN3+ (including adeno-carcinoma-in-situ) and cervical cancer (ITT).

Time frame: 12 months after the date of the positive screening test

Detection rate ratios of CIN2+ (and CIN1+, CIN3+, cancer) in the per-protocol analysis, restricted to women who adhered to the foreseen follow-up.

Time frame: 12 months after the date of the positive screening test

Locations

Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw, Warsaw, Poland

Linked Papers

2023-11-17

HPV testing in Polish population-based cervical cancer screening programme (HIPPO project)—study protocol of a randomised healthcare policy trial

Abstract Background An Organised Cervical Cancer Screening Programme (OCCSP) was started in Poland in 2006/2007. Each woman aged 25 to 59 is eligible for a free Pap test every 3 years in OCCSP. Despite implementation of the OCCSP, the age-standardised cervical cancer (CC) incidence and mortality rates in 2019 were 7.3/100 000 and 3.9/100 000 respectively and were still higher than those in Western European countries with well-organised screening programmes. Apart from low coverage of the OCCSP, suboptimal performance of the screening test (conventional cytology) may be partially responsible for this situation. Several countries have already incorporated high risk Human Papillomavirus (hrHPV) testing in CC screening as a more sensitive tool reducing the risk of missing precancerous lesions and allowing for extension of screening intervals. The European Guidelines for Quality Assurance in Cervical Cancer Screening recommend pilot evaluation of a new screening test in country-specific conditions before its implementation. Methods The HIPPO project (HPV testing In Polish POpulation-based cervical cancer screening program) is a randomised health services study nested in the OCCSP in Poland. The project will randomise 33 000 women aged 30–59 years to cytology or hrHPV testing (ratio: 1:1) with age stratification. In the cytology arm women with repeated Atypical Squamous Cells of Undetermined Significance (ASC-US) or ≥ Low–Grade Squamous Intraepithelial Lesions (LSIL) are referred for colposcopy. In the other arm, hrHPV ( +) women with ≥ ASC-US reflex Liquid-Based Cytology (LBC) are referred for colposcopy. Primary endpoints include detection rates of histologically confirmed high grade intraepithelial lesions or worse (CIN2 +) in each arm. Discussion This pilot randomised healthcare study nested in the OCCSP in Poland will assess and compare the performance of hrHPV testing to current standard—cytology in order to make decisions on implementation of HPV-based screening in the country. Trial registration This randomised healthcare service study was prospectively registered at https://clinicaltrials.gov/ (identifier: NCT04111835, protocol ID 28/2019) on 19th of September 2019.

Linked Investigators

Andrzej Nowakowski

Patrycja Glinska