Cancer of CervixNCT05709730
Follow-up of Cell Changes in the Cervix
An observational study of Cancer of Cervix, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The purpose of the study is to follow up on cell changes detected in the cervical cancer screening program, to investigate whether they are handled with adequate quality. Read more about this study
- Who is it for?
- Ages 23 to 80 years, women only
- Conditions the study is for
- Cancer of Cervix
- What is being tested?
- HPV genotyping
- How many people
- 885 participants
- Where
- 1 siteSweden
- Study dates
- 7 Jul 2016to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 23 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women aged 23 years and older, residing in the Stockholm-Gotland region of Sweden who had an AGC diagnosis in a cervical cytology sample between February 17th, 2014, and December 31st, 2018. For eligibility, an HPV test result and a subsequent histopathological diagnosis is also required. HPV testing performed 40 days before or after the index sampling date is considered to indicate the HPV status of the index AGC.
Who may be able to join
- women with an AGC diagnosis between February 17, 2014 and December 31, 2018
- 23-80 years old
- resident of the Stockholm-Gotland region of Sweden
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to follow up on cell changes detected in the cervical cancer screening program, to investigate whether they are handled with adequate quality.
Read the detailed description
The aim of the study is to clarify whether follow-up of cell changes is carried out with sufficiently good quality. It is nationally recommended to perform an HPV test on mild cell changes and only refer to clinical follow-up if you are HPV positive. Descriptive statistics on HPV-testing and follow-up of quality are not available today. If HPV testing has not already been performed, archived samples with glandular cell changes will be HPV-analyzed in Cobas 4800 HPV-polymerase chain reaction (PCR), which shows data on the presence of HPV and Luminex-PCR, which shows which HPV types the samples have. Women with low-grade squamous cell changes (ASCUS and CIN1) with simultaneous HPV analysis will be followed up with data from the Swedish National Cervical Screening Registry (NKCx) from the last ten years. A register linkage with data from NKCx and the National Cancer Registry at the National Board of Health and Welfare will be carried out to determine which women have developed gynecological cancer, cervical cancer and/or pre-cancer (cancer in situ). A follow-up review of reported original cytological (cell samples) and histological (tissue samples) diagnoses will be performed by cytodiagnostics and cytopathologists, to verify the correct diagnosis.
Statistics on collection of non-organized cell samples after a partial negative sample where follow-up is not recommended are produced in aggregated form in the form of an extract from NKCx
- Conditions
- Cancer of Cervix
- Being tested
- HPV genotyping
- 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.
HPV genotypingDiagnostic test
HPV genotyping of samples classified that were positive for "other HPV"
| Study group | Role | What they receive |
|---|---|---|
| Women aged 26-80 with atypical glandular cell (AGC) cytology result | Women in the capital region of Sweden with AGC, a concomitant human papillomavirus (HPV) analysis, and a histopathology. Receives: Diagnostic Test: HPV genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical intraepithelial neoplasia 3 (CIN3+)
Risk for developing CIN3+ or worse depending on HPV type
Measured: 2014-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start7 Jul 2016
- Primary completion31 Dec 2019
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of CervixStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 885 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joakim Dillner, Karolinska University Hospital
- Investigators
- Joakim Dillner, MD PhD, Principal investigator, Joakim Dillner. Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709730
- Sponsor's protocol ID
- AGC
- Status last verified
- Oct 2024
- First submitted
- 24 Jan 2023
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available through the Swedish National Cervical Screening Registry and on request from the PI.
Publications
Norman I, Yilmaz E, Hjerpe A, Hortlund M, Elfstrom KM, Dillner J. Atypical glandular cells and development of cervical cancer: Population-based cohort study. Int J Cancer. 2022 Dec 1;151(11):2012-2019. doi: 10.1002/ijc.34242. Epub 2022 Aug 27.
PubMed 36029205
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Cell Changes in the Cervix
- ClinicalTrials.gov ID
- NCT05709730
- Acronym / sponsor ID
- AGC
- Conditions
- Cancer of Cervix
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 885 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 7 Jul 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 2 Feb 2023 (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 purpose of the study is to follow up on cell changes detected in the cervical cancer screening program, to investigate whether they are handled with adequate quality.
Detailed description
The aim of the study is to clarify whether follow-up of cell changes is carried out with sufficiently good quality. It is nationally recommended to perform an HPV test on mild cell changes and only refer to clinical follow-up if you are HPV positive. Descriptive statistics on HPV-testing and follow-up of quality are not available today. If HPV testing has not already been performed, archived samples with glandular cell changes will be HPV-analyzed in Cobas 4800 HPV-polymerase chain reaction (PCR), which shows data on the presence of HPV and Luminex-PCR, which shows which HPV types the samples have. Women with low-grade squamous cell changes (ASCUS and CIN1) with simultaneous HPV analysis will be followed up with data from the Swedish National Cervical Screening Registry (NKCx) from the last ten years. A register linkage with data from NKCx and the National Cancer Registry at the National Board of Health and Welfare will be carried out to determine which women have developed gynecological cancer, cervical cancer and/or pre-cancer (cancer in situ). A follow-up review of reported original cytological (cell samples) and histological (tissue samples) diagnoses will be performed by cytodiagnostics and cytopathologists, to verify the correct diagnosis.
Statistics on collection of non-organized cell samples after a partial negative sample where follow-up is not recommended are produced in aggregated form in the form of an extract from NKCx
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women aged 26-80 with atypical glandular cell (AGC) cytology result | – | Diagnostic Test: HPV genotypingWomen in the capital region of Sweden with AGC, a concomitant human papillomavirus (HPV) analysis, and a histopathology. |
Who may qualify
- Ages
- 23 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women aged 23 years and older, residing in the Stockholm-Gotland region of Sweden who had an AGC diagnosis in a cervical cytology sample between February 17th, 2014, and December 31st, 2018. For eligibility, an HPV test result and a subsequent histopathological diagnosis is also required. HPV testing performed 40 days before or after the index sampling date is considered to indicate the HPV status of the index AGC.
Key inclusion criteria (3 listed)
- women with an AGC diagnosis between February 17, 2014 and December 31, 2018
- 23-80 years old
- resident of the Stockholm-Gotland region of Sweden
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| HPV genotypingHPV genotyping of samples classified that were positive for "other HPV" | Diagnostic test | Women aged 26-80 with atypical glandular cell (AGC) cytology result |
Primary outcome
cervical intraepithelial neoplasia 3 (CIN3+)
Time frame: 2014-2018
Risk for developing CIN3+ or worse depending on HPV type
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Background: PubMed 36029205Norman I, Yilmaz E, Hjerpe A, Hortlund M, Elfstrom KM, Dillner J. Atypical glandular cells and development of cervical cancer: Population-based cohort study. Int J Cancer. 2022 Dec 1;151(11):2012-2019. doi: 10.1002/ijc.34242. Epub 2022 Aug 27.
- Individual participant dataSharing planned: Yes. Data available through the Swedish National Cervical Screening Registry and on request from the PI.
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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.
Joakim Dillner, MD PhD principal investigator
Joakim Dillner. Professor
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 Cancer of Cervix, run by Karolinska University Hospital at 1 site in Sweden.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 10 Oct 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
cervical intraepithelial neoplasia 3 (CIN3+) (time frame: 2014-2018). 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 NCT05709730, which also lists 1 linked publication.
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 10 Oct 2024.