Ignite Creation Date:
2024-05-06 @ 1:45 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04111835
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2019-09-19
Brief Title:
HPV Testing In Polish POpulation-based Cervical Cancer Screening Program
Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Organization:
Maria Sklodowska-Curie National Research Institute of Oncology
Study Overview
Official Title:
HPV Testing In Polish POpulation-based Cervical Cancer Screening Program - a Randomized Healthcare Policy Trial
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIPPOPROJECT
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
Detailed Description:
The study assumes randomized assumption of 33000 women aged 30-59 to cytology or HR HPV test in a 11 ratio with age stratification three strata 30-39 40-49 and 50-59 years
Patients are recruited by the Cervical Cancer Prevention Clinic at the Department of Cancer Prevention at the Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw main centre and 8 more sites from distant regions of Poland Lublin Masovian Silesian Swietokrzyskie and West Pomeranian Voivodeship All sites are selected through a tendering process and have to fulfil several criteria for inclusion into the project active participation in the OCCSP being certified for HPV testing with the chosen clinically validated hrHPV DNA assaysto obtain results representative for the entire country
Gynaecological clinics
Lublin Voivodeship
Non-Public Health Care Department MED -SPEC in Zamosc
Plus Clinic in Zamosc
Medical Center - Diagnostic in Lukow
Masovian Voivodeship
Medical Center - Diagnostic Siedlce Kleeberg Street 2 Minsk Mazowiecki Dąbrówki Street 2 Lukow Krynka Street 1C Nur Drohiczyńska Street 8 Sterdyn Lipowa Street 1A 08-320 Sterdyn Zelechow Piłsudskiego Street 34 Strachowka Norwida Street 6A Wierzbno Wierzbno Street 88 Latowicz Nowowiejska Street 34 Wielgolas
Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
St John Paul II Mazovian Provincial Hospital in Siedlce
Silesian Voivodeship
Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw on Gliwice
SUPRA-MED in Bielsko-Biała
SUPRA-MED in Wilkowice
Gynecology and Obstetrics Clinic K na Żeromskiego in Wodzisław Slaski
Medical Center in Rybnik
Non-public Health Care JARO in Wodzisław Slaski
Non-public Health Care EVA in Lubliniec
SIKORNIK Clinic in Gliwice
Swietokrzyskie Voivodeship
- Holy Cross Cancer Centre in Kielce
West Pomeranian Voivodeship
Non-public Health Care MULTIMED Gynecology and Obstetrics in Koszalin Koszalin Monte Casino Street 13 Koszalin Sw Wojciecha Street 1 Koszalin Kolejowa Street 71 Koszalin Lelewela Street7 Bedzino Street 18
Hospital in Szczecinek
Cytologicalmolecular laboratories
Maria Sklodowska-Curie National Research Institute of Oncology Roentgen Street 5 Warsaw Armii Krajowej Street 15 44-102 Gliwice branch in Gliwice
Holy Cross Cancer Centre Prezydent Stefan Artwinski Street 3 25-734 Kielce
Medical Center - Diagnostic Niklowa Street 9 08-110 Siedlce
ALAB Laboratories Stępinska Street 2230 00-739 Warsaw
Non-public Health Care Center MEDITEST Medical Diagnostics Bronislawy Street 14D 70-533 Szczecin
Non-public Health Care MULTIMED Gynecology and Obstetrics Monte Casino Street 13 75-414 Koszalin
Non-Public Health Care Department of Pathomorphology ALFAMED Edward Cwierz Maciej Cwierz Jana Kilinskiego Street 78 22a-400 Zamosc
Femina Medical Centre Klodnicka Street 23 40-703 Katowice
Colposcopy clinics
Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
Non-public Health Care Center MEDITEST Medical Diagnostics in Szczecin
Maria Sklodowska-Curie National Research Institute of Oncology in Gliwice
Non-public Health Care MULTIMED Gynecology and Obstetrics
St John Paul II Mazovian Provincial Hospital in Siedlce
Femina Medical Centre in Katowice
Holy Cross Cancer Centre in Kielce
Medical Center - Diagnostic in Siedlce
Non-Public Health Care Department of Pathomorphology ALFAMED Edward Cwierz Maciej Cwierz in Zamosc
The primary endpoint is the detection rate DR of histologically confirmed CIN2 or higher in each screening arm and detection rate ratio DRR of CIN2 in HPV test vs cytology arm in intention-to-treat ITT analysis Secondary endpoints include detection rate ratio of CIN1 CIN3 including adenocarcinoma in situ and invasive CC in both ITT and per-protocol PP analysis restricted to women who adhered to the foreseen follow-up
Other outcome measures are 1 distribution of women by the screening test results 2 referral rate for colposcopy 3 compliance with referral for colposcopy 4 positive predictive value of referral for colposcopy calculated for each screening test and separately by histology results no CIN CIN1 CIN2 CIN3 AIS CIN2 CIN3 invasive cancer squamousadenocarcinoma 5 DR of histologically confirmed CIN2 in patients with hrHPV positive test two NILM LBCs six months apart and a positive CINtePlus Cytology andor Qiasure test 6 DRR of histologically confirmed CIN2 after CINtec PLUS Cytology test vs QIASURE methylation test 7 yield of use of CINtec PLUS Cytology test vs QIASURE methylation test in terms of detection rate of histologically confirmed CIN2
Additionally biobanking of cytological samples taken from patients participating in the HIPPO Project is planned in Maria Sklodowska-Curie National Research Institute of Oncology for the purpose of potential future restrospective analyses if new cervical cancer screening technologies emerge
The study was approved by the Bioethics Committee of National Research Institute of Oncology ID 28201912020
Patients are recruited by the Cervical Cancer Prevention Clinic at the Department of Cancer Prevention at the Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw main centre and 8 more sites from distant regions of Poland Lublin Masovian Silesian Swietokrzyskie and West Pomeranian Voivodeship All sites are selected through a tendering process and have to fulfil several criteria for inclusion into the project active participation in the OCCSP being certified for HPV testing with the chosen clinically validated hrHPV DNA assaysto obtain results representative for the entire country
Gynaecological clinics
Lublin Voivodeship
Non-Public Health Care Department MED -SPEC in Zamosc
Plus Clinic in Zamosc
Medical Center - Diagnostic in Lukow
Masovian Voivodeship
Medical Center - Diagnostic Siedlce Kleeberg Street 2 Minsk Mazowiecki Dąbrówki Street 2 Lukow Krynka Street 1C Nur Drohiczyńska Street 8 Sterdyn Lipowa Street 1A 08-320 Sterdyn Zelechow Piłsudskiego Street 34 Strachowka Norwida Street 6A Wierzbno Wierzbno Street 88 Latowicz Nowowiejska Street 34 Wielgolas
Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
St John Paul II Mazovian Provincial Hospital in Siedlce
Silesian Voivodeship
Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw on Gliwice
SUPRA-MED in Bielsko-Biała
SUPRA-MED in Wilkowice
Gynecology and Obstetrics Clinic K na Żeromskiego in Wodzisław Slaski
Medical Center in Rybnik
Non-public Health Care JARO in Wodzisław Slaski
Non-public Health Care EVA in Lubliniec
SIKORNIK Clinic in Gliwice
Swietokrzyskie Voivodeship
- Holy Cross Cancer Centre in Kielce
West Pomeranian Voivodeship
Non-public Health Care MULTIMED Gynecology and Obstetrics in Koszalin Koszalin Monte Casino Street 13 Koszalin Sw Wojciecha Street 1 Koszalin Kolejowa Street 71 Koszalin Lelewela Street7 Bedzino Street 18
Hospital in Szczecinek
Cytologicalmolecular laboratories
Maria Sklodowska-Curie National Research Institute of Oncology Roentgen Street 5 Warsaw Armii Krajowej Street 15 44-102 Gliwice branch in Gliwice
Holy Cross Cancer Centre Prezydent Stefan Artwinski Street 3 25-734 Kielce
Medical Center - Diagnostic Niklowa Street 9 08-110 Siedlce
ALAB Laboratories Stępinska Street 2230 00-739 Warsaw
Non-public Health Care Center MEDITEST Medical Diagnostics Bronislawy Street 14D 70-533 Szczecin
Non-public Health Care MULTIMED Gynecology and Obstetrics Monte Casino Street 13 75-414 Koszalin
Non-Public Health Care Department of Pathomorphology ALFAMED Edward Cwierz Maciej Cwierz Jana Kilinskiego Street 78 22a-400 Zamosc
Femina Medical Centre Klodnicka Street 23 40-703 Katowice
Colposcopy clinics
Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
Non-public Health Care Center MEDITEST Medical Diagnostics in Szczecin
Maria Sklodowska-Curie National Research Institute of Oncology in Gliwice
Non-public Health Care MULTIMED Gynecology and Obstetrics
St John Paul II Mazovian Provincial Hospital in Siedlce
Femina Medical Centre in Katowice
Holy Cross Cancer Centre in Kielce
Medical Center - Diagnostic in Siedlce
Non-Public Health Care Department of Pathomorphology ALFAMED Edward Cwierz Maciej Cwierz in Zamosc
The primary endpoint is the detection rate DR of histologically confirmed CIN2 or higher in each screening arm and detection rate ratio DRR of CIN2 in HPV test vs cytology arm in intention-to-treat ITT analysis Secondary endpoints include detection rate ratio of CIN1 CIN3 including adenocarcinoma in situ and invasive CC in both ITT and per-protocol PP analysis restricted to women who adhered to the foreseen follow-up
Other outcome measures are 1 distribution of women by the screening test results 2 referral rate for colposcopy 3 compliance with referral for colposcopy 4 positive predictive value of referral for colposcopy calculated for each screening test and separately by histology results no CIN CIN1 CIN2 CIN3 AIS CIN2 CIN3 invasive cancer squamousadenocarcinoma 5 DR of histologically confirmed CIN2 in patients with hrHPV positive test two NILM LBCs six months apart and a positive CINtePlus Cytology andor Qiasure test 6 DRR of histologically confirmed CIN2 after CINtec PLUS Cytology test vs QIASURE methylation test 7 yield of use of CINtec PLUS Cytology test vs QIASURE methylation test in terms of detection rate of histologically confirmed CIN2
Additionally biobanking of cytological samples taken from patients participating in the HIPPO Project is planned in Maria Sklodowska-Curie National Research Institute of Oncology for the purpose of potential future restrospective analyses if new cervical cancer screening technologies emerge
The study was approved by the Bioethics Committee of National Research Institute of Oncology ID 28201912020
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 28201912020 | OTHER | Bioethics Committee of the Maria Sklodowska-Curie National Research Institute of Oncology Warsaw Poland | None |