HPV Testing In Polish POpulation-based Cervical Cancer Screening Program.
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

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 33,000 women aged 30-59 to cytology or HR HPV test
      in a 1:1 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 assays)to 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"

      Cytological&molecular 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 22/30, 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
      (squamous/adenocarcinoma)); (5) DR of histologically confirmed CIN2+ in patients with hrHPV
      positive test, two NILM LBCs six months apart and a positive CINtePlus Cytology and/or
      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: 28/2019/1/2020).
    

Intervention name(s): Offering an alternative cervical cancer screening method - hrHPV molecular testing.
Intervention type(s): Diagnostic Test
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: cervical cancer; cervical screening; HPV testing