Cervical CancerHIPPOPROJECTNCT04111835
HPV Testing In Polish POpulation-based Cervical Cancer Screening Program.
A study testing Offering an alternative cervical cancer screening method - hrHPV molecular testing. in people with Cervical Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 59 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Offering an alternative cervical cancer screening method - hrHPV molecular testing.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33,000 participants
- Where
- 1 sitePoland
- Study dates
- 28 Oct 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- -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)
Who cannot join
- -women with screening Pap test within the preceding three years in the OCCSP
Trial locations and contacts
1 site in 1 country.
Poland1 site
Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
Warsaw
About this study
Official title: HPV Testing In Polish POpulation-based Cervical Cancer Screening Program - a Randomized Healthcare Policy Trial
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.
Read the 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).
- Conditions
- Cervical Cancer
- Being tested
- Offering an alternative cervical cancer screening method - hrHPV molecular testing.
- Keywords
- cervical cancer, cervical screening, HPV testing
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Offering an alternative cervical cancer screening method - hrHPV molecular testing.Diagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Conventional exfoliative cytology/LBC | No intervention | 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. |
| hrHPV molecular testing | Experimental | 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 Receives: Diagnostic Test: Offering an alternative cervical cancer screening method - hrHPV molecular testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of histologically confirmed CIN2 or worse in each screening arm
Measured: 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
Measured: 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).
Measured: 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.
Measured: 12 months after the date of the positive screening test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start28 Oct 2019
- Primary completion3 Nov 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111835
- Sponsor's protocol ID
- 28/2019
- Other IDs
- 28/2019/1/2020
- Acronym
- HIPPOPROJECT
- Status last verified
- Jan 2024
- First submitted
- 19 Sep 2019
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nowakowski A, Macios A, Glinska P, Chmielewska A, Janik B, Jedrzejewska I, Klimiuk A, Chmielik E, Bobkiewicz P, Kapusniak E, Podolski J, Prokurat E, Arbyn M, Kaminski MF. Primary Human Papillomavirus Screening Versus Cytology for Detection of Cervical Intraepithelial Neoplasia Grade 2 or Higher in Poland: a Parallel-Group, Randomized Controlled Trial. Lancet Reg Health Eur. 2026 May 8;66:101697. doi: 10.1016/j.lanepe.2026.101697. eCollection 2026 Jul.
PubMed 42403920Glinska 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.
PubMed 37978452
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Testing In Polish POpulation-based Cervical Cancer Screening Program - a Randomized Healthcare Policy Trial
- ClinicalTrials.gov ID
- NCT04111835
- Acronym / sponsor ID
- HIPPOPROJECT / 28/2019
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, cervical screening, HPV testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33,000 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Ministry of Health, Poland
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional exfoliative cytology/LBC | No intervention | –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. |
| hrHPV molecular testing | Experimental | Diagnostic Test: Offering an alternative cervical cancer screening method - 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 |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -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)
Key exclusion criteria (1 listed)
- -women with screening Pap test within the preceding three years in the OCCSP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | hrHPV molecular testing |
Primary outcome
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)
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
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Derived from this study: PubMed 42403920Nowakowski A, Macios A, Glinska P, Chmielewska A, Janik B, Jedrzejewska I, Klimiuk A, Chmielik E, Bobkiewicz P, Kapusniak E, Podolski J, Prokurat E, Arbyn M, Kaminski MF. Primary Human Papillomavirus Screening Versus Cytology for Detection of Cervical Intraepithelial Neoplasia Grade 2 or Higher in Poland: a Parallel-Group, Randomized Controlled Trial. Lancet Reg Health Eur. 2026 May 8;66:101697. doi: 10.1016/j.lanepe.2026.101697. eCollection 2026 Jul.
- Derived from this study: PubMed 37978452Glinska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Offering an alternative cervical cancer screening method - hrHPV molecular testing. in people with Cervical Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of histologically confirmed CIN2 or worse in each screening arm (time frame: 12 months after the date of the positive screening test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04111835, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.