HPV Testing In Polish POpulation-based Cervical Cancer Screening Program.
HIPPOPROJECT
2 other identifiers
interventional
33,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2019
CompletedFirst Posted
Study publicly available on registry
October 1, 2019
CompletedStudy Start
First participant enrolled
October 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 2, 2024
January 1, 2024
3 years
September 19, 2019
February 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Detection rate of histologically confirmed CIN2 or worse in each screening arm
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
12 months after the date of the positive screening test
Secondary Outcomes (2)
Detection rate ratio of CIN1+, CIN3+ (including adeno-carcinoma-in-situ) and cervical cancer (ITT).
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.
12 months after the date of the positive screening test
Other Outcomes (6)
Distribution of women by the screening test results
12 months after the date of the positive screening test
Referral rate for colposcopy for each screening test
12 months after the date of the positive screening test
Positive predictive value of referral for colposcopy calculated for each screening test and separately
12 months after the date of the positive screening test
- +3 more other outcomes
Study Arms (2)
Conventional exfoliative cytology/LBC
NO INTERVENTIONAccording to current Polish guidelines: ASC-US: repeat Pap testing in 6 months - current standard protocol LSIL - repeat Pap testing in 6 months or refer for colposcopy (by the decision of cytologist) - current standard protocol ASC-H and higher and all glandular lesions - refer for colposcopy - current standard protocol Colposcopy-targeted biopsies will be taken in agreement with national guidelines. If screening cytology is negative -\> rescreening after 3 years.
hrHPV molecular testing
EXPERIMENTALhrHPV-positive - reflex LBC: Abnormal reflex LBC (ASC-US or worse) -\> colposcopy Normal reflex LBC -\> repeat LBC in 6 months Positive - colposcopy Negative -\> The CINtec PLUS Cytology and The QIASURE methylation test The CINtec PLUS Cytology Positive -\> colposcopy Negative -\> rescreen in 3 years The QIASURE methylation test Positive -\> colposcopy Negative -\> rescreen in 3 years Colposcopy-targeted biopsies will be taken in agreement with national guidelines. HPV-negative - rescreen in 5 years
Interventions
Women randomized to this screening strategy group will take a hrHPV molecular test. hrHPV-positive - reflex LBC: Abnormal reflex LBC (ASC-US or worse) -\> colposcopy Normal reflex LBC -\> repeat LBC in 6 months Positive - colposcopy Negative - rescreen in 3 years HPV-negative - rescreen in 5 years
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- women with screening Pap test within the preceding three years in the OCCSP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
Warsaw, Poland
Related Publications (1)
Glinska P, Komerska K, Janik B, Olkowicz J, Jedrzejewska I, Macios A, Wieszczy P, Kaminski MF, Arbyn M, Nowakowski A. HPV testing in Polish population-based cervical cancer screening programme (HIPPO project)-study protocol of a randomised healthcare policy trial. BMC Cancer. 2023 Nov 17;23(1):1118. doi: 10.1186/s12885-023-11597-5.
PMID: 37978452DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2019
First Posted
October 1, 2019
Study Start
October 28, 2019
Primary Completion
November 3, 2022
Study Completion
December 31, 2023
Last Updated
February 2, 2024
Record last verified: 2024-01