Healthy Adult ParticipantsMARGOTNCT07902388
Methylation Analyses for Gynaecological Research Through Home-based Self-sampling
A study testing Colli-Pee 20 mL device with UCM and Evalyn Brush in people with Healthy Adult Participants and Gynecological Disease, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
The goal of the MARGOT study is to collect self-samples, such as first-void urine and vaginal samples, from people without cancer and compare them with samples from people with gynecological (pre-)cancers collected in other studies, to better understand the differences in biological markers present in these samples… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants, Gynecological Disease
- What is being tested?
- Colli-Pee 20 mL device with UCM and Evalyn Brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Apr 2026to 31 Dec 2032
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals having female genital organs, regardless of their gender identity
- Participant is 18 years or older at the time of signing the informed consent form
- Participant must be able to understand the (Dutch) information consent form and what the study is about
- Participant must be able to provide written informed consent and take urine- and vaginal self-samples
- Individual has a Belgian nationality
Who cannot join
- Individuals that underwent hysterectomy or ovariectomy
- Pregnant individuals or 6 months post-partum
- (History of) (pre)cancer, or an ongoing diagnostic work-up or treatment for oncological concerns
- Unable to give informed consent or to take urine- or vaginal self-samples
- Participation in another interventional study. However, participation in another low-interventional or observational study is allowed
- Individuals who have (a history) of postmenopausal bleeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University of Antwerp, Center for the Evaluation of Vaccination, Vaccinopolis
Edegem, Antwerp, 2650
Tine Pinxteren, MSc, 04 76 01 48 43 ext. 32, CEV-HPVstudies@uantwerpen.be
About this study
The goal of the MARGOT study is to collect self-samples, such as first-void urine and vaginal samples, from people without cancer and compare them with samples from people with gynecological (pre-)cancers collected in other studies, to better understand the differences in biological markers present in these samples between these two groups.
Read the detailed description
To ensure the validity and interpretability of research findings, it is essential to compare study outcomes against an appropriate reference population. This study will collect first-void urine and vaginal self-samples from people without cancer (cancer-free controls), which will serve as a comparator for individuals diagnosed with a gynecological (pre-)cancer. These cancer-free controls are recruited via different ways (e.g., social media, volunteer databases, posters/flyers in healthcare institutions). Participants have the option to collect their samples at home or on site at the study center. A questionnaire will provide more information about the presence of risk factors and participants' experiences with the self-sampling methods.
- Conditions
- Healthy Adult Participants, Gynecological Disease
- Being tested
- Colli-Pee 20 mL device with UCM, Evalyn Brush
- Keywords
- Biomarkers, Self-sampling, First-void urine, Vaginal self-sample, Screening
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colli-Pee 20 mL device with UCMDevice
Participants will collect a first-void urine (the initial part of the urine stream) sample with the 20 mL Colli-Pee device prefilled with urine conservation medium (UCM, DNA Genotek, Canada). This sample can be taken at home or on site.
Evalyn BrushDevice
Participants will collect a vaginal self-sample with the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home or on site.
| Study group | Role | What they receive |
|---|---|---|
| Sample collection | Experimental | Participants will collect one first-void urine sample and one vaginal self-sample at home or at the study center. Receives: Device: Colli-Pee 20 mL device with UCM; Device: Evalyn Brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of (epi)genetic biomarkers between controls and cases
The data collected within this study (controls) will be compared to the data from the gynecological (pre-)cancer patients (cases) that are collected during a concurrent study: COMBISCREEN (B3002023000030) and MYSSELF study (B3002025000175).
The primary objective of the presented MARGOT study is to facilitate the identification of (epi)genetic biomarkers for the detection of gynecological (pre-)cancers. This will be achieved through the recruitment of sufficient healthy volunteers for a robust comparison of control and (pre-)cancer samples. This evaluation will be conducted using first-void urine and vaginal self-samples that are analysed with (methylation-) detection techniques.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start13 Apr 2026
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wiebren Tjalma, Universiteit Antwerpen
- Investigators
- Wiebren A.A. Tjalma, MD, PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902388
- Sponsor's protocol ID
- B3002026000034
- Acronym
- MARGOT
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylation Analyses for Gynaecological Research Through Home-based Self-sampling
- ClinicalTrials.gov ID
- NCT07902388
- Acronym / sponsor ID
- MARGOT / B3002026000034
- Conditions
- Healthy Adult Participants, Gynecological Disease
- Keywords
- Biomarkers, Self-sampling, First-void urine, Vaginal self-sample, Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 28 Oct 2026 (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 goal of the MARGOT study is to collect self-samples, such as first-void urine and vaginal samples, from people without cancer and compare them with samples from people with gynecological (pre-)cancers collected in other studies, to better understand the differences in biological markers present in these samples between these two groups.
Detailed description
To ensure the validity and interpretability of research findings, it is essential to compare study outcomes against an appropriate reference population. This study will collect first-void urine and vaginal self-samples from people without cancer (cancer-free controls), which will serve as a comparator for individuals diagnosed with a gynecological (pre-)cancer. These cancer-free controls are recruited via different ways (e.g., social media, volunteer databases, posters/flyers in healthcare institutions). Participants have the option to collect their samples at home or on site at the study center. A questionnaire will provide more information about the presence of risk factors and participants' experiences with the self-sampling methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample collection | Experimental | Device: Colli-Pee 20 mL device with UCM, Device: Evalyn BrushParticipants will collect one first-void urine sample and one vaginal self-sample at home or at the study center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals having female genital organs, regardless of their gender identity
- Participant is 18 years or older at the time of signing the informed consent form
- Participant must be able to understand the (Dutch) information consent form and what the study is about
- Participant must be able to provide written informed consent and take urine- and vaginal self-samples
- Individual has a Belgian nationality
Key exclusion criteria (6 listed)
- Individuals that underwent hysterectomy or ovariectomy
- Pregnant individuals or 6 months post-partum
- (History of) (pre)cancer, or an ongoing diagnostic work-up or treatment for oncological concerns
- Unable to give informed consent or to take urine- or vaginal self-samples
- Participation in another interventional study. However, participation in another low-interventional or observational study is allowed
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 |
|---|---|---|
| Colli-Pee 20 mL device with UCMParticipants will collect a first-void urine (the initial part of the urine stream) sample with the 20 mL Colli-Pee device prefilled with urine conservation medium (UCM, DNA Genotek, Canada). This sample can be taken at home or on site. | Device | Sample collection |
| Evalyn BrushParticipants will collect a vaginal self-sample with the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home or on site. | Device | Sample collection |
Primary outcome
Comparison of (epi)genetic biomarkers between controls and cases
Time frame: 48 months
The data collected within this study (controls) will be compared to the data from the gynecological (pre-)cancer patients (cases) that are collected during a concurrent study: COMBISCREEN (B3002023000030) and MYSSELF study (B3002025000175). The primary objective of the presented MARGOT study is to facilitate the identification of (epi)genetic biomarkers for the detection of gynecological (pre-)cancers. This will be achieved through the recruitment of sufficient healthy volunteers for a robust comparison of control and (pre-)cancer samples. This evaluation will be conducted using first-void urine and vaginal self-samples that are analysed with (methylation-) detection techniques.
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Wiebren A.A. Tjalma, MD, PhD principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colli-Pee 20 mL device with UCM and Evalyn Brush in people with Healthy Adult Participants and Gynecological Disease, run by Universiteit Antwerpen 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 6 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: looking for participants now, as of the sponsor's last update on 28 Oct 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?
Contact Tine Pinxteren, MSc (476014843 ext. 32, tine.pinxteren@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of (epi)genetic biomarkers between controls and cases (time frame: 48 months). 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 28 Oct 2026.