Cervical CancerESSAGNCT05656976
Efficacy of Offering a Self-sampling Device by the GP to Reach Underscreened Women
A study testing Provision of self sampling device by the GP and Provision of self sampling device by letter in people with Cervical Cancer, run by University Ghent at 1 site in Belgium.
Trial summary
The ESSAG trial invests the impact of offering a free self-sampling device (SSD) on the cervical cancer screening rate of underscreened women. This study is aimed at women between the age of 31 and 64 who did not have a smear taken during the last 6 years. Read more about this study
- Who is it for?
- Ages 31 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Provision of self sampling device by the GP and Provision of self sampling device by letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,375 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2023to 31 Jul 2026
- Phase
- Interventional
- 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 31 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women between 31-64 years old
- living in Flanders
- eligible for the Flemish actions with regard to population screening
- without a smear registered in the Belgian Cancer Registry in the last 6 years
- registered as GMD patient in one of the participating GP practices
Who cannot join
- hysterectomy
- pregnancy
- (past) diagnosis of cervical cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Offering a Self-sampling Device by the General Practitioner to Reach Women Underscreened in the Routine Cervical Cancer Screening Program Compared to Sending Reminder Letters by the Screening Organization
The ESSAG trial invests the impact of offering a free self-sampling device (SSD) on the cervical cancer screening rate of underscreened women. This study is aimed at women between the age of 31 and 64 who did not have a smear taken during the last 6 years. In order to assess the effect of a) providing the SSD, and b) the intervention of the general practitioner (GP) (either face-to-face, either by sending the SSD by letter), a cluster randomized control trial is set up with three arms. The ESSAG trial evolves from a collaboration between Universiteit Gent and Vrije Universiteit Brussel, Katholieke Universiteit Leuven, Universiteit Antwerpen, Sciensano, het Centrum voor Kankeropsporing en het Belgisch Kankerregister, and is funded by "Kom Op Tegen Kanker".
- Conditions
- Cervical Cancer
- Being tested
- Provision of self sampling device by the GP, Provision of self sampling device by letter
- Keywords
- Prevention, Screening
- 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.
Provision of self sampling device by the GPOther
In a group of 45 GP practices, over a course of 6 months, all long-term unscreened women with a GMD will be addressed by their GP when they consult for any reason. The GP will discuss the pros and cons of screening for cervical cancer, the various options for screening for cervical cancer including the possibility of using a SSD. For this, the GP can use on accessible brochure and video materials. After the woman agrees, she is given a self-taking kit that she can use when and where it suits her and send it to the lab with the prepaid envelope. The woman is informed of the result of the Human Papillomavirus test result by her GP according to the usual way in the practice (e.g. via letter, by phone or during the next consultation).
Provision of self sampling device by letterOther
In the second arm, a second group of 45 GP practices in Flanders will be recruited. With the intervention of the Centre for Cancer Prevention (Flanders), 25 at randomly selected long-term unscreened women with a Global Medical Form (in dutch: 'Globaal Medisch Dossier, GMD) in one of these practices will receive an envelope containing a letter of invitation from their GP for cervical cancer screening, a brochure with the advantages and disadvantages of cervical cancer screening and more specifically the use of a self-taking kit, and a self-taking kit. If the woman wishes, she can use the kit when and where it suits her and send it to the lab with the pre-paid envelope. As in arm A, the woman will be informed of the Human Papilloma Virus test result by her GP according to the usual way in the practice (e.g., by letter, by phone or during the next consultation). All women will receive a study-related reminder letter after 4 months.
| Study group | Role | What they receive |
|---|---|---|
| A Self sampling device (SSD) provided by the general practitioner (GP) | Experimental | A self sampling device will be provided by the GP. Receives: Other: Provision of self sampling device by the GP |
| B Self sampling device provided by letter | Experimental | A self sampling device will be provided by letter. Receives: Other: Provision of self sampling device by letter |
| C (control arm) Recommendation letter | No intervention | Following the usual care procedure, a random sample of 1125 Flemish women who meet the same inclusion criteria as in arm A and B and are not included in one of the latter arms is drawn by "Centrum voor Kankeropsporing" (CvKO) from Heracles, the database of the Flemish screening program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Age-standardised response rates in each arm and the differences between arms will be calculated, in a per protocol (PP) and intention-to-treat (ITT) analysis.
As the goal is to reveal to what extent the respective approach (providing a self sampling device (SSD) with different levels of general practitioner (GP) involvement) succeeds in reaching vulnerable women, analyses will take into account a comprehensive list of covariates by logistic regression accounting for cluster effects. These covariates include trial arm, GP-office characteristics, as well as demographic information of the patient on origin and socio-economical background provided by the "Kruispuntbank voor Sociale Zekerheid (KSZ)".
Measured: Up to 6 months
Secondary outcomes (4)
Participation rate
The participation rate will be calculated from arm A to answer questions at public health level, i.e. the population effect of the intervention by GP's on increasing cervical cancer screening coverage in underscreened women.
For participation rate, the denominator are all women who belong to the target group for that specific GP-office (women between 31-64y, not screened within 6y, etc).
Measured: Up to 6 months
Cost-effectiveness analysis
A cost-effectiveness analysis will also be performed, addressing the additional number of women screened per 1,000€ in interventions A and B versus control intervention C.
Measured: Up to 15 months
Feasibility analysis (semi-structured interviews with GP's)
In order to explore the potential roll-out of the study within the Flemish screening programme, the investigators will also perform a feasibility study. Through interviews with 20-30 GPs who participated in arm A, a feasibility analysis will reveal the strengths and pitfalls of the intervention.
Measured: Up to 4 months after the intervention in their practice
Response rate (follow-up cytology test)
Although this study is not powered for inter-arm differences in follow-up after an abnormal screening test result, compliance analysis will be performed with the following indicators: screen-test positivity rates, proportion with invalid screen-test results, proportion of screen-test positives that have the foreseen follow-up tests.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Sep 2023
- Primary completion31 Aug 2024
- Study completion31 Jul 2026 (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 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial (RCT)
- Masking
- None (open label)
- Enrolment
- 3,375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Kom Op Tegen Kanker, Sciensano, Centrum voor Kankeropsporing, Belgian Cancer Registry, KU Leuven, Vrije Universiteit Brussel, Universiteit Antwerpen
- Responsible party
- Sponsor
- Investigators
- Kaatje Van Roy, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656976
- Sponsor's protocol ID
- ONZ-2022-0250
- Acronym
- ESSAG
- Status last verified
- Feb 2026
- First submitted
- 23 Nov 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gezels E, Van Roy K, Arbyn M, Coursier P, Devroey D, Martens P, Simoens C, Vaes B, Van Herck K, Vankrunkelsven P, Verhoeven V, Willems S. The ESSAG-trial protocol: A randomized controlled trial evaluating the efficacy of offering a self-sampling kit by the GP to reach women underscreened in the routine cervical cancer screening program. Contemp Clin Trials. 2024 Sep;144:107617. doi: 10.1016/j.cct.2024.107617. Epub 2024 Jul 6.
PubMed 38977179
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Offering a Self-sampling Device by the General Practitioner to Reach Women Underscreened in the Routine Cervical Cancer Screening Program Compared to Sending Reminder Letters by the Screening Organization
- ClinicalTrials.gov ID
- NCT05656976
- Acronym / sponsor ID
- ESSAG / ONZ-2022-0250
- Conditions
- Cervical Cancer
- Keywords
- Prevention, Screening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,375 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Kom Op Tegen Kanker, Sciensano, Centrum voor Kankeropsporing, Belgian Cancer Registry, KU Leuven, Vrije Universiteit Brussel, Universiteit Antwerpen
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 20 Dec 2022 (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 ESSAG trial invests the impact of offering a free self-sampling device (SSD) on the cervical cancer screening rate of underscreened women. This study is aimed at women between the age of 31 and 64 who did not have a smear taken during the last 6 years. In order to assess the effect of a) providing the SSD, and b) the intervention of the general practitioner (GP) (either face-to-face, either by sending the SSD by letter), a cluster randomized control trial is set up with three arms. The ESSAG trial evolves from a collaboration between Universiteit Gent and Vrije Universiteit Brussel, Katholieke Universiteit Leuven, Universiteit Antwerpen, Sciensano, het Centrum voor Kankeropsporing en het Belgisch Kankerregister, and is funded by "Kom Op Tegen Kanker".
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| A Self sampling device (SSD) provided by the general practitioner (GP) | Experimental | Other: Provision of self sampling device by the GPA self sampling device will be provided by the GP. |
| B Self sampling device provided by letter | Experimental | Other: Provision of self sampling device by letterA self sampling device will be provided by letter. |
| C (control arm) Recommendation letter | No intervention | –Following the usual care procedure, a random sample of 1125 Flemish women who meet the same inclusion criteria as in arm A and B and are not included in one of the latter arms is drawn by "Centrum voor Kankeropsporing" (CvKO) from Heracles, the database of the Flemish screening program. |
Who may qualify
- Ages
- 31 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women between 31-64 years old
- living in Flanders
- eligible for the Flemish actions with regard to population screening
- without a smear registered in the Belgian Cancer Registry in the last 6 years
- registered as GMD patient in one of the participating GP practices
Key exclusion criteria (3 listed)
- hysterectomy
- pregnancy
- (past) diagnosis of cervical cancer
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 |
|---|---|---|
| Provision of self sampling device by the GPIn a group of 45 GP practices, over a course of 6 months, all long-term unscreened women with a GMD will be addressed by their GP when they consult for any reason. The GP will discuss the pros and cons of screening for cervical cancer, the various options for screening for cervical cancer including the possibility of using a SSD. For this, the GP can use on accessible brochure and video materials. After the woman agrees, she is given a self-taking kit that she can use when and where it suits her and send it to the lab with the prepaid envelope. The woman is informed of the result of the Human Papillomavirus test result by her GP according to the usual way in the practice (e.g. via letter, by phone or during the next consultation). | Other | A Self sampling device (SSD) provided by the general practitioner (GP) |
| Provision of self sampling device by letterIn the second arm, a second group of 45 GP practices in Flanders will be recruited. With the intervention of the Centre for Cancer Prevention (Flanders), 25 at randomly selected long-term unscreened women with a Global Medical Form (in dutch: 'Globaal Medisch Dossier, GMD) in one of these practices will receive an envelope containing a letter of invitation from their GP for cervical cancer screening, a brochure with the advantages and disadvantages of cervical cancer screening and more specifically the use of a self-taking kit, and a self-taking kit. If the woman wishes, she can use the kit when and where it suits her and send it to the lab with the pre-paid envelope. As in arm A, the woman will be informed of the Human Papilloma Virus test result by her GP according to the usual way in the practice (e.g., by letter, by phone or during the next consultation). All women will receive a study-related reminder letter after 4 months. | Other | B Self sampling device provided by letter |
Primary outcome
Response rate
Time frame: Up to 6 months
Age-standardised response rates in each arm and the differences between arms will be calculated, in a per protocol (PP) and intention-to-treat (ITT) analysis. As the goal is to reveal to what extent the respective approach (providing a self sampling device (SSD) with different levels of general practitioner (GP) involvement) succeeds in reaching vulnerable women, analyses will take into account a comprehensive list of covariates by logistic regression accounting for cluster effects. These covariates include trial arm, GP-office characteristics, as well as demographic information of the patient on origin and socio-economical background provided by the "Kruispuntbank voor Sociale Zekerheid (KSZ)".
4 secondary outcomes
Participation rate
Time frame: Up to 6 months
Cost-effectiveness analysis
Time frame: Up to 15 months
Feasibility analysis (semi-structured interviews with GP's)
Time frame: Up to 4 months after the intervention in their practice
Response rate (follow-up cytology test)
Time frame: Up to 3 months
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 17 Feb 2026.
- Derived from this study: PubMed 38977179Gezels E, Van Roy K, Arbyn M, Coursier P, Devroey D, Martens P, Simoens C, Vaes B, Van Herck K, Vankrunkelsven P, Verhoeven V, Willems S. The ESSAG-trial protocol: A randomized controlled trial evaluating the efficacy of offering a self-sampling kit by the GP to reach women underscreened in the routine cervical cancer screening program. Contemp Clin Trials. 2024 Sep;144:107617. doi: 10.1016/j.cct.2024.107617. Epub 2024 Jul 6.
- 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.
Kaatje Van Roy principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provision of self sampling device by the GP and Provision of self sampling device by letter in people with Cervical Cancer, run by University Ghent at 1 site in Belgium.
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 5 inclusion and 3 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 17 Feb 2026. 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 Belgium. 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?
Response rate (time frame: Up to 6 months). 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 NCT05656976, 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 17 Feb 2026.