Cervical CancerNCT04783649
Clinical Validation of Cervical Cancer Screening Methods
An observational study of Cervical Cancer and Cervical Dysplasia, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
Trial summary
This single-institution cross-sectional non-inferiority validation study evaluates alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Cervical Dysplasia, Human Papilloma Virus
- What is being tested?
- Papanicolaou cytological test, Local cytological test (H&E stain) and Validated HPV DNA Test
- How many people
- 2,500 participants
- Where
- 1 siteRussia
- Study dates
- 13 Jul 2020to 1 Jul 2023
- Phase
- Observational
- 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 25-65 year-old women without prior history of malignancy referred to colposcopy enriched with a population sample of women from several primary healthcare facilities.
Who may be able to join
- Age between 25 and 65 years old Referral to colposcopy or to a primary screening test Signed informed consent
Who cannot join
- Prior history of malignancy or cervical dysplasia Prior history of cervical dysplasia
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, 197758
Olga Smirnova, MD, PhD, +7 812 439 9555, ssmirnova.oa@gmail.com
About this study
Official title: Clinical Validation of Cervical Cancer Screening Methods in St. Petersburg, Russia
This single-institution cross-sectional non-inferiority validation study evaluates alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests.
Read the detailed description
Cervical cytology practices are different across the world. While the Pap test became the cornerstone of the highly-effective cervical cancer screening in the countries that initially implemented population-based programs in the 60s and the 70s, alternative staining techniques were implemented in the Soviet Union. The tradition to apply other staining techniques than conventional Pap test remained unchanged in the national screening program implemented in the 2010s in Russia. As a new alternative option HPV testing showed effectiveness in screening women older than 30. The acceptable sensitivity and specificity of a screening test are crucial in population-based screening, that is why validation against "the gold standard" should be the first step in the process of program implementation. The objective of this study is to evaluate alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests in the population of 25-65 yo women without prior history of malignancy referred to colposcopy enriched with a population sample of women from several primary healthcare facilities referred to a primary screening test.
- Conditions
- Cervical Cancer, Cervical Dysplasia, Human Papilloma Virus
- Being tested
- Papanicolaou cytological test, Local cytological test (H&E stain), Validated HPV DNA Test, Local HPV test, Colposcopy
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papanicolaou cytological testDiagnostic test
Cervical smear stained using conventional Papanicolaou technique.
Local cytological test (H&E stain)Diagnostic test
Cervical smear stained using conventional hematoxylin and eosin staining techniques
Validated HPV DNA TestDiagnostic test
Digene HC2 HPV DNA Test
Local HPV testDiagnostic test
RealBest DNA HPV HR genotype (differential detection of human papillomavirus types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 DNA)
ColposcopyDiagnostic test
Women with positive cytology results are referred to colposcopy and biopsy
| Study group | Role | What they receive |
|---|---|---|
| High risk group | Women in the age group between 25 and 65 years old without prior history of malignancy referred to colposcopy Receives: Diagnostic Test: Papanicolaou cytological test; Diagnostic Test: Local cytological test (H&E stain); Diagnostic Test: Validated HPV DNA Test; Diagnostic Test: Local HPV test; Diagnostic Test: Colposcopy | |
| Population sample | A population sample of women in the age group between 25 and 65 years old from several primary healthcare facilities to primary cervical screening Receives: Diagnostic Test: Papanicolaou cytological test; Diagnostic Test: Local cytological test (H&E stain); Diagnostic Test: Validated HPV DNA Test; Diagnostic Test: Local HPV test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Cervical screening tests sensitivity
Measured: 24 months
Specificity
Cervical screening tests specificity
Measured: 24 months
Secondary outcomes (2)
HPV prevalence by type
HPV prevalence by type based on genotyping in the population sample
Measured: 24 months
Cervical dysplasia prevalence
Prevalence of cervical dysplasia in the population sample
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start13 Jul 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783649
- Sponsor's protocol ID
- CC-001
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Cervical Cancer Screening Methods in St. Petersburg, Russia
- ClinicalTrials.gov ID
- NCT04783649
- Acronym / sponsor ID
- CC-001
- Conditions
- Cervical Cancer, Cervical Dysplasia, Human Papilloma Virus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 5 Mar 2021 (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.
This single-institution cross-sectional non-inferiority validation study evaluates alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests.
Detailed description
Cervical cytology practices are different across the world. While the Pap test became the cornerstone of the highly-effective cervical cancer screening in the countries that initially implemented population-based programs in the 60s and the 70s, alternative staining techniques were implemented in the Soviet Union. The tradition to apply other staining techniques than conventional Pap test remained unchanged in the national screening program implemented in the 2010s in Russia. As a new alternative option HPV testing showed effectiveness in screening women older than 30. The acceptable sensitivity and specificity of a screening test are crucial in population-based screening, that is why validation against "the gold standard" should be the first step in the process of program implementation. The objective of this study is to evaluate alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests in the population of 25-65 yo women without prior history of malignancy referred to colposcopy enriched with a population sample of women from several primary healthcare facilities referred to a primary screening test.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk group | – | Diagnostic Test: Papanicolaou cytological test, Diagnostic Test: Local cytological test (H&E stain), Diagnostic Test: Validated HPV DNA Test, Diagnostic Test: Local HPV test, Diagnostic Test: ColposcopyWomen in the age group between 25 and 65 years old without prior history of malignancy referred to colposcopy |
| Population sample | – | Diagnostic Test: Papanicolaou cytological test, Diagnostic Test: Local cytological test (H&E stain), Diagnostic Test: Validated HPV DNA Test, Diagnostic Test: Local HPV testA population sample of women in the age group between 25 and 65 years old from several primary healthcare facilities to primary cervical screening |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 25-65 year-old women without prior history of malignancy referred to colposcopy enriched with a population sample of women from several primary healthcare facilities.
Key inclusion criteria (1 listed)
- Age between 25 and 65 years old Referral to colposcopy or to a primary screening test Signed informed consent
Key exclusion criteria (1 listed)
- Prior history of malignancy or cervical dysplasia Prior history of cervical dysplasia
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 |
|---|---|---|
| Papanicolaou cytological testCervical smear stained using conventional Papanicolaou technique. | Diagnostic test | High risk group, Population sample |
| Local cytological test (H&E stain)Cervical smear stained using conventional hematoxylin and eosin staining techniques | Diagnostic test | High risk group, Population sample |
| Validated HPV DNA TestDigene HC2 HPV DNA Test | Diagnostic test | High risk group, Population sample |
| Local HPV testRealBest DNA HPV HR genotype (differential detection of human papillomavirus types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 DNA) | Diagnostic test | High risk group, Population sample |
| ColposcopyWomen with positive cytology results are referred to colposcopy and biopsy | Diagnostic test | High risk group |
Primary outcome
Sensitivity
Time frame: 24 months
Cervical screening tests sensitivity
Specificity
Time frame: 24 months
Cervical screening tests specificity
2 secondary outcomes
HPV prevalence by type
Time frame: 24 months
Cervical dysplasia prevalence
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Cervical Dysplasia, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
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: status not confirmed, as of the sponsor's last update on 5 Mar 2021. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 24 months). 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?
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 5 Mar 2021.