Carcinoma in Situ of Uterine CervixNCT02002468
Follow-up of Abnormal and Inadequate Smear-test Results
A study testing Test result sent by letter and Test result conveyed by general practitioners in people with Carcinoma in Situ of Uterine Cervix, run by University of Aarhus at 1 site in Denmark.
Trial summary
Denmark has a higher incidence of cervical cancer than other Nordic countries, although all Danish women (aged 23-65) are screened regularly to identify possible cervical dysplasia or asymptomatic invasive cancer. Annually 40 000 women receives an abnormal or inadequate test result and a follow-up recommendation. Read more about this study
- Who is it for?
- Ages 23 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Carcinoma in Situ of Uterine Cervix
- What is being tested?
- Test result sent by letter and Test result conveyed by general practitioners
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125,000 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Feb 2017
- 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 23 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- woman with a pap-smear test
Who cannot join
- less than 23 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up of Abnormal and Inadequate Test Results in the Danish Cervical Cancer Screening Program.
Denmark has a higher incidence of cervical cancer than other Nordic countries, although all Danish women (aged 23-65) are screened regularly to identify possible cervical dysplasia or asymptomatic invasive cancer.
Annually 40 000 women receives an abnormal or inadequate test result and a follow-up recommendation.
Read more
However problems with delayed follow-up may threaten the effectiveness of the Danish Cervical Cancer Screening Program, as 20% of women are delayed and dysplasia potentially can progress into cancer.
Delayed follow-up is found in situations where women either consciously or unconsciously postpone follow-up, or because of organizational aspects of the screening program, where communication regarding test results can fail either in content or with delay.This study will evaluate two interventions designed to increase follow-up:
- A letter with the test result and potential recommendation for follow up will be sent to the women (RCT). The intention is to ensure that all women will be notified about the test result, quickly, homogenously and in layman's written language, still with the opportunity to contact or be contacted by the general practitioner, if there is special needs. Furthermore, it is assumed that general practitioner consultations regarding delivery of normal test results will decrease, so that cost savings is a potential side benefit
- Electronic reminder to the general practitioner if women have not had the recommended follow up, giving the general practioner´s an opportunity to remind the women (retro perspective cohort study).
The results will be of great importance to the future organisation of cervical and colorectal cancer screening programmes in Denmark, but will also have international interest because of their similar challenges.
- Conditions
- Carcinoma in Situ of Uterine Cervix
- Being tested
- Test result sent by letter, Test result conveyed by general practitioners
- Keywords
- Risk Communication, Follow-up, Organisation of screening
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test result sent by letterOther
Test result conveyed by general practitionersOther
| Study group | Role | What they receive |
|---|---|---|
| Test result sent by letter | Experimental | The pap-smear test result is sent by letter directly to the women. Women in need of follow up are in the letter recommended to contact their general practitioner. Receives: Other: Test result sent by letter; Other: Test result conveyed by general practitioners |
| Test result conveyed by general practitioners | Active comparator | In Denmark it is a standard procedure that general practitioners convey the pap-smear test results to the women. Receives: Other: Test result conveyed by general practitioners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women with timely follow-up
The proportion of women followed up will be calculated as cumulated incidence proportions according to four timeframes (undesirable early, as recommended, late, very late), and be compared by relative risks. The results will be presented in totals and separately depending on the test result (normal/inadequate/Bethesda classification 2001/HPV).
Measured: 1½ year
Secondary outcomes (1)
Frequency of general practitioner contacts (consultations/telephone calls /e-mails) regarding conveying the smear test result.
The two randomisation groups will be compared with respect to contacts with general practitioner after the smear test the first days, weeks, months after the general practitioner is notified of the screening result.
Measured: Three months after the smear test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2014
- Study completionFeb 2017 (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 Carcinoma in Situ of Uterine CervixStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Vedsted, Study director, Center for Research in Cancer Diagnosis in Primary Care - (CaP), Aarhus UniversityFlemming Bro, Study director, The Research Unit of General Practice in Aarhus, Aarhus UniversityBerit S Andersen, Study director, The Department of Public Health Programmes at Regional Hospital Randers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002468
- Sponsor's protocol ID
- Cervix cancer screening
- Status last verified
- Dec 2015
- First submitted
- 29 Nov 2013
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kristiansen BK, Andersen B, Bro F, Svanholm H, Vedsted P. Direct notification of cervical cytology results to women improves follow-up in cervical cancer screening - A cluster-randomised trial. Prev Med Rep. 2018 Nov 23;13:118-125. doi: 10.1016/j.pmedr.2018.11.015. eCollection 2019 Mar.
PubMed 30568870
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Abnormal and Inadequate Test Results in the Danish Cervical Cancer Screening Program.
- ClinicalTrials.gov ID
- NCT02002468
- Acronym / sponsor ID
- Cervix cancer screening
- Conditions
- Carcinoma in Situ of Uterine Cervix
- Keywords
- Risk Communication, Follow-up, Organisation of screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125,000 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Feb 2017 (estimated)
- First posted
- 5 Dec 2013 (estimated)
- 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.
Denmark has a higher incidence of cervical cancer than other Nordic countries, although all Danish women (aged 23-65) are screened regularly to identify possible cervical dysplasia or asymptomatic invasive cancer.
Annually 40 000 women receives an abnormal or inadequate test result and a follow-up recommendation.
However problems with delayed follow-up may threaten the effectiveness of the Danish Cervical Cancer Screening Program, as 20% of women are delayed and dysplasia potentially can progress into cancer.
Delayed follow-up is found in situations where women either consciously or unconsciously postpone follow-up, or because of organizational aspects of the screening program, where communication regarding test results can fail either in content or with delay.This study will evaluate two interventions designed to increase follow-up:
- A letter with the test result and potential recommendation for follow up will be sent to the women (RCT). The intention is to ensure that all women will be notified about the test result, quickly, homogenously and in layman's written language, still with the opportunity to contact or be contacted by the general practitioner, if there is special needs. Furthermore, it is assumed that general practitioner consultations regarding delivery of normal test results will decrease, so that cost savings is a potential side benefit
- Electronic reminder to the general practitioner if women have not had the recommended follow up, giving the general practioner´s an opportunity to remind the women (retro perspective cohort study).
The results will be of great importance to the future organisation of cervical and colorectal cancer screening programmes in Denmark, but will also have international interest because of their similar challenges.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test result sent by letter | Experimental | Other: Test result sent by letter, Other: Test result conveyed by general practitionersThe pap-smear test result is sent by letter directly to the women. Women in need of follow up are in the letter recommended to contact their general practitioner. |
| Test result conveyed by general practitioners | Active comparator | Other: Test result conveyed by general practitionersIn Denmark it is a standard procedure that general practitioners convey the pap-smear test results to the women. |
Who may qualify
- Ages
- 23 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- woman with a pap-smear test
Key exclusion criteria (1 listed)
- less than 23 years
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 |
|---|---|---|
| Test result sent by letter | Other | Test result sent by letter |
| Test result conveyed by general practitioners | Other | Test result conveyed by general practitioners, Test result sent by letter |
Primary outcome
Proportion of women with timely follow-up
Time frame: 1½ year
The proportion of women followed up will be calculated as cumulated incidence proportions according to four timeframes (undesirable early, as recommended, late, very late), and be compared by relative risks. The results will be presented in totals and separately depending on the test result (normal/inadequate/Bethesda classification 2001/HPV).
1 secondary outcome
Frequency of general practitioner contacts (consultations/telephone calls /e-mails) regarding conveying the smear test result.
Time frame: Three months after the smear test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Derived from this study: PubMed 30568870Kristiansen BK, Andersen B, Bro F, Svanholm H, Vedsted P. Direct notification of cervical cytology results to women improves follow-up in cervical cancer screening - A cluster-randomised trial. Prev Med Rep. 2018 Nov 23;13:118-125. doi: 10.1016/j.pmedr.2018.11.015. eCollection 2019 Mar.
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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.
Peter Vedsted study director
Center for Research in Cancer Diagnosis in Primary Care - (CaP), Aarhus University
Flemming Bro study director
The Research Unit of General Practice in Aarhus, Aarhus University
Berit S Andersen study director
The Department of Public Health Programmes at Regional Hospital Randers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test result sent by letter and Test result conveyed by general practitioners in people with Carcinoma in Situ of Uterine Cervix, run by University of Aarhus at 1 site in Denmark.
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 15 Sep 2016. 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 Denmark. 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?
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?
Proportion of women with timely follow-up (time frame: 1½ year). 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 NCT02002468, 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 15 Sep 2016.