Gynaecological CancersMYSSELFNCT07902375
Methylation Profiling in Self-samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
A study testing Colli-Pee 20 mL device with UCM and Evalyn Brush in people with Gynaecological Cancers and Ovarian Cancer, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
The goal of the MYSSELF study is to investigate which biological markers (i.e., (epi)genetic biomarkers) found in self-collected samples, such as first-void urine and vaginal samples, are linked to the presence of endometrial, ovarian, vulvar, or vaginal (pre-)cancer or to postmenopausal bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynaecological Cancers, Ovarian Cancer, Endometrial Cancer
- 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
- 730 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Jun 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals having female genital organs, regardless of their gender identity
- 18 years old or older at the time of signing the informed consent form
- Diagnosed with either endometrial, ovarian, vulvar, or vaginal cancer irrespective of stage; diagnosed with one of their precursor lesions; or individuals with postmenopausal bleeding
- Has not started any form of cancer treatment prior to study enrolment
- Written informed consent must be obtained from each participant
- The participant is able to understand the information brochure and what the study is about
Who cannot join
- Individuals that underwent hysterectomy or ovariectomy
- Pregnant individuals or 6 weeks post-partum
- Treatment for endometrial, ovarian, vulvar, or vaginal (pre-)cancer in the last 6 months before participation in the study
- Participating in another interventional clinical study (where, e.g., a medical device, drug, or vaccine is evaluated) at the same time as participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.
- Unable to give informed consent
- Participants with a history or current evidence of any condition or abnormality that might confound the results of the study, or when it is not in the best interest of the participant to participate, in the opinion of the investigator.
- Participant has severe anemia
- Participant received a blood transfusion two weeks before sample collection
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 Hospital of Antwerp (UZA)
Edegem, Antwerp, 2650
Wiebren A.A. Tjalma, MD, PhD, 03 821 32 50 ext. +32, wiebren.tjalma@uza.be
About this study
The goal of the MYSSELF study is to investigate which biological markers (i.e., (epi)genetic biomarkers) found in self-collected samples, such as first-void urine and vaginal samples, are linked to the presence of endometrial, ovarian, vulvar, or vaginal (pre-)cancer or to postmenopausal bleeding. Samples collected by clinicians from the cervix or vulva, as well as blood and tissue samples, will be used for comparison. The study will explore whether these markers could help improve earlier and less invasive detection of gynecological cancers in the future.
Read the detailed description
Gynecological cancers include cancers of the cervix, endometrium, ovaries, vulva, and vagina. Early detection of these cancers is important, because treatment is more effective before the disease has advanced. At the moment, cervical cancer is the only gynecological cancer with a population-based screening program. For the other types (endometrial, ovarian, vulvar, and vaginal cancer), only diagnostic methods are available, but these are often uncomfortable for patients or not sufficiently specific. Hence, this study aims to improve early detection by looking for new biological markers (i.e., (epi)genetic biomarkers) in less-invasive samples that are associated with the presence of gynecological cancers. For this, different sample types are collected from patients with endometrial, ovarian, vulvar, or vaginal (pre-)cancer (n=100/(pre-)cancer) or from individuals with postmenopausal bleeding (n=330). These samples include self-samples collected at home (first-void urine (Colli-Pee 20 mL prefilled with urine conservation medium (UCM)) and vaginal self-sample (Evalyn brush)), clinician-collected cervical/vulvar samples, and blood samples. Only when a tissue sample is already being taken as part of the participant's standard treatment or diagnostic follow-up, it will be used for this study as well. As such, participants do not undergo additional invasive procedures as part of the study. All these samples are collected before any treatment begins (e.g., surgery, chemotherapy, radiotherapy…). For all analyses, current diagnostic results (e.g., dilation \& curettage, transvaginal ultrasonography, blood biomarker CA-125, vulvoscopy, echography, imaging (CT, PET, MRI)) and cancer (histology) diagnoses will be used as the final diagnosis. A questionnaire will provide more information about the presence of risk factors and participants' experiences with the self-sampling methods.
- Conditions
- Gynaecological Cancers, Ovarian Cancer, Endometrial Cancer, Vulvar Cancer, Vaginal Cancer, Postmenopausal Bleeding
- 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
- Ovarian Neoplasms, Endometrial Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms
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 the day before or the day of the planned consultation at the hospital or at the hospital itself.
Evalyn BrushDevice
Participants will collect a vaginal self-sample with the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home the day before or the day of the planned consultation at the hospital or at the hospital itself.
| Study group | Role | What they receive |
|---|---|---|
| Sample collection | Experimental | Participants will collect one first-void urine sample and one vaginal self-sample at home, the day before or the day of their planned consultation at the hospital or at the hospital itself. During the hospital visit, an additional clinician-collected cervical and/or vulvar sample and a blood sample will be collected for the study. If a tissue sample is already being taken as part of the participant's standard treatment or diagnostic follow-up, it will also be used for this study. Current diagnostic results (e.g., dilation \& curettage, transvaginal ultrasonography, blood biomarker CA-125, vulvoscopy, echography, imaging (CT, PET, MRI)) and cancer (histology) diagnoses will be used as the final diagnosis. 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.
Number and overview of biomarkers associated with the presence of gynecological (pre-)cancers
The primary objective of this study is to determine the feasibility of detecting (epi)genetic biomarkers in participants with (pre-)cancer (endometrial, ovarian, vulvar, or vaginal cancer). This evaluation will be conducted using multiple sample types: self-samples (first-void urine and vaginal samples), clinician-collected cervical/vulvar samples, blood samples, and tissue samples.
Measured: 48 months
Secondary outcomes (2)
Comparison of the biomarkers in different sample types
The secondary objective is to compare the presence of biomarkers across different sample types (self-samples (first-void urine and vaginal samples), clinician-collected cervical/vulvar samples, blood samples, and tissue samples).
Measured: 48 months
Association of biomarkers and presence of postmenopausal bleeding
The third objective is to explore the association of the identified biomarkers with clinical characteristics in individuals with postmenopausal bleeding, a symptom that can arise from a variety of conditions, including but not limited to endometrial cancer.
Measured: 72 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 start19 Jun 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 Gynaecological CancersStudies 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
- 730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Principal investigator, Wiebren Tjalma, Universiteit Antwerpen
- Investigators
- Wiebren A.A. Tjalma, MD, PhD, Principal investigator, University Hospital of Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902375
- Sponsor's protocol ID
- B3002025000175
- Acronym
- MYSSELF
- 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 Profiling in Self-samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
- ClinicalTrials.gov ID
- NCT07902375
- Acronym / sponsor ID
- MYSSELF / B3002025000175
- Conditions
- Gynaecological Cancers, Ovarian Cancer, Endometrial Cancer, Vulvar Cancer, Vaginal Cancer, Postmenopausal Bleeding
- Keywords
- Biomarkers, Self-sampling, First-void urine, Vaginal self-sample, Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 730 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 19 Jun 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 MYSSELF study is to investigate which biological markers (i.e., (epi)genetic biomarkers) found in self-collected samples, such as first-void urine and vaginal samples, are linked to the presence of endometrial, ovarian, vulvar, or vaginal (pre-)cancer or to postmenopausal bleeding. Samples collected by clinicians from the cervix or vulva, as well as blood and tissue samples, will be used for comparison. The study will explore whether these markers could help improve earlier and less invasive detection of gynecological cancers in the future.
Detailed description
Gynecological cancers include cancers of the cervix, endometrium, ovaries, vulva, and vagina. Early detection of these cancers is important, because treatment is more effective before the disease has advanced. At the moment, cervical cancer is the only gynecological cancer with a population-based screening program. For the other types (endometrial, ovarian, vulvar, and vaginal cancer), only diagnostic methods are available, but these are often uncomfortable for patients or not sufficiently specific. Hence, this study aims to improve early detection by looking for new biological markers (i.e., (epi)genetic biomarkers) in less-invasive samples that are associated with the presence of gynecological cancers. For this, different sample types are collected from patients with endometrial, ovarian, vulvar, or vaginal (pre-)cancer (n=100/(pre-)cancer) or from individuals with postmenopausal bleeding (n=330). These samples include self-samples collected at home (first-void urine (Colli-Pee 20 mL prefilled with urine conservation medium (UCM)) and vaginal self-sample (Evalyn brush)), clinician-collected cervical/vulvar samples, and blood samples. Only when a tissue sample is already being taken as part of the participant's standard treatment or diagnostic follow-up, it will be used for this study as well. As such, participants do not undergo additional invasive procedures as part of the study. All these samples are collected before any treatment begins (e.g., surgery, chemotherapy, radiotherapy…). For all analyses, current diagnostic results (e.g., dilation \& curettage, transvaginal ultrasonography, blood biomarker CA-125, vulvoscopy, echography, imaging (CT, PET, MRI)) and cancer (histology) diagnoses will be used as the final diagnosis. 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, the day before or the day of their planned consultation at the hospital or at the hospital itself. During the hospital visit, an additional clinician-collected cervical and/or vulvar sample and a blood sample will be collected for the study. If a tissue sample is already being taken as part of the participant's standard treatment or diagnostic follow-up, it will also be used for this study. Current diagnostic results (e.g., dilation \& curettage, transvaginal ultrasonography, blood biomarker CA-125, vulvoscopy, echography, imaging (CT, PET, MRI)) and cancer (histology) diagnoses will be used as the final diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals having female genital organs, regardless of their gender identity
- 18 years old or older at the time of signing the informed consent form
- Diagnosed with either endometrial, ovarian, vulvar, or vaginal cancer irrespective of stage; diagnosed with one of their precursor lesions; or individuals with postmenopausal bleeding
- Has not started any form of cancer treatment prior to study enrolment
- Written informed consent must be obtained from each participant
Key exclusion criteria (8 listed)
- Individuals that underwent hysterectomy or ovariectomy
- Pregnant individuals or 6 weeks post-partum
- Treatment for endometrial, ovarian, vulvar, or vaginal (pre-)cancer in the last 6 months before participation in the study
- Participating in another interventional clinical study (where, e.g., a medical device, drug, or vaccine is evaluated) at the same time as participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.
- Unable to give informed consent
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 the day before or the day of the planned consultation at the hospital or at the hospital itself. | Device | Sample collection |
| Evalyn BrushParticipants will collect a vaginal self-sample with the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home the day before or the day of the planned consultation at the hospital or at the hospital itself. | Device | Sample collection |
Primary outcome
Number and overview of biomarkers associated with the presence of gynecological (pre-)cancers
Time frame: 48 months
The primary objective of this study is to determine the feasibility of detecting (epi)genetic biomarkers in participants with (pre-)cancer (endometrial, ovarian, vulvar, or vaginal cancer). This evaluation will be conducted using multiple sample types: self-samples (first-void urine and vaginal samples), clinician-collected cervical/vulvar samples, blood samples, and tissue samples.
2 secondary outcomes
Comparison of the biomarkers in different sample types
Time frame: 48 months
Association of biomarkers and presence of postmenopausal bleeding
Time frame: 72 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 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Gynaecological Cancers
RecruitingObservational study
GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
Gynaecological Cancers
Not yet recruitingObservational study
Protocol for Non-invasive Gynaecological Surveillance in Lynch Syndrome
Lynch Syndrome
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingPhase 3
Prehabilitation in Gynaecological Cancer Patients
Ovarian Cancer, Ovarian Cancer Stage III
Recruiting
More Representative Vaginal Temperature Measurements With a Hyperthermia Pelotte During Hyperthermia Treatments for Gynaecological Cancer.
Gynaecologic Cancer
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
University Hospital of Antwerp
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 Gynaecological Cancers and Ovarian Cancer, 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 6 inclusion and 8 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?
Number and overview of biomarkers associated with the presence of gynecological (pre-)cancers (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.