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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111835
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
Ministry of Health, Poland
Information provided by (Responsible Party):
Maria Sklodowska-Curie Institute - Oncology Center

Brief Summary:
The HIPPOPROJECT 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Diagnostic Test: Offering an alternative cervical cancer screening method - hrHPV molecular testing. Not Applicable

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).

The study will start on September 2019 at the Department of Cervical Cancer Prevention at the Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw. To obtain results representative for the entire country several sites are planned for inclusion in the study from 2020 in 10 regions of Poland.

Primary end-points include the detection rate of histologically confirmed high grade intraepithelial lesions or worse in each screening arm. Selected secondary endpoints include detection rate ratios, colposcopy referral rates and positive predictive values of referral for colposcopy.

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 has been approved by a local bioethics committee.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: HPV Testing In Polish POpulation-based Cervical Cancer Screening Program - a Randomized Healthcare Policy Trial
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
No Intervention: Conventional exfoliative cytology/LBC

According 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.

Experimental: hrHPV molecular testing

hrHPV-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

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

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





Primary Outcome Measures :
  1. Detection rate of histologically confirmed CIN2 or worse in each screening arm [ Time Frame: 12 months after the date of the positive screening test ]
  2. Detection rate ratio of CIN2+ in HPV test vs cytology arm (and detection rate ratios between the hrHPV test and cytology) [ Time Frame: 12 months after the date of the positive screening test ]

    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



Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Other Outcome Measures:
  1. Distribution of women by the screening test results [ Time Frame: 12 months after the date of the positive screening test ]
    This is for conventional cytology and LBC - according the modified Bethesda 2014 system used in the program. We will analyze the number of women due to the result of screening test in each arm.

  2. Referral rate for colposcopy for each screening test [ Time Frame: 12 months after the date of the positive screening test ]
    Analyses will be performed on data collected in SIMP. We will check the compliance on referral for colposcopy for each screening.

  3. Positive predictive value of referral for colposcopy calculated for each screening test and separately [ Time Frame: 12 months after the date of the positive screening test ]
    Histology: No CIN, CIN1, CIN2, CIN3, AIS, CIN2+, CIN3+, invasive cancer (squamous/adenocarcinoma).

  4. Detection rates of histologically confirmed CIN2+ in patients with second negative LBC result [ Time Frame: 12 months after the date of the positive screening test ]
    Detection rates of histologically confirmed CIN2+ in patients with second negative LBC result: after CINtec PLUS Cytology test and after QIASURE methylation test; detection rate ratio of histologically confirmed CIN2+ after CINTEC test vs after QIASURE methylation test

  5. Yield of use of additional diagnostic tests in terms of detection rate of histologically confirmed CIN2+ [ Time Frame: 12 months after the date of the positive screening test ]
    Number of women with histologically confirmed CIN2+ after CINtec test/number of women screened with HPV test

  6. Yield of use of additional diagnostic tests in terms of detection rate of histologically [ Time Frame: 12 months after the date of the positive screening test ]
    Number of women with histologically confirmed CIN2+ after QIASURE methylation test/number of women screened with HPV test



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111835


Contacts
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Contact: Andrzej Nowakowski, MD, PhD +48 603942962 Andrzej.Nowakowski@coi.pl
Contact: Patrycja Potyrała, MD +48 665259019 patrycja.potyrala@coi.pl

Locations
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Poland
Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw Recruiting
Warsaw, Poland
Contact: Andrzej Nowakowski, MD, PhD    +48 603942962    Andrzej.Nowakowski@coi.pl   
Contact: Patrycja Potyrała, MD    +48 665259019    patrycja.potyrala@coi.pl   
Sponsors and Collaborators
Maria Sklodowska-Curie Institute - Oncology Center
Ministry of Health, Poland
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Responsible Party: Maria Sklodowska-Curie Institute - Oncology Center
ClinicalTrials.gov Identifier: NCT04111835    
Other Study ID Numbers: 28/2019
28/2019/1/2020 ( Other Identifier: Bioethics Committee of the Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, )
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Sklodowska-Curie Institute - Oncology Center:
cervical cancer
cervical screening
HPV testing
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases