Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers (MYSSELF)

November 3, 2026 updated by: Wiebren Tjalma, Universiteit Antwerpen

The goal of the MYSSELF (Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers) 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

730

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Recruiting
        • University Hospital of Antwerp (UZA)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Exclusion criteria related to blood withdrawal:

  • The participant has severe anemia.
  • The participant received a blood transfusion two weeks before sample collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants Providing Samples for Biomarker Analysis

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.
Device: Colli-Pee 20 mL device with UCM

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.

Device: Evalyn Brush

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the biomarkers in different sample types
Time Frame: 48 months

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).
48 months
Association of biomarkers and presence of postmenopausal bleeding
Time Frame: 72 months

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.
72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Collaborators

University Hospital, Antwerp

Investigators

  • Principal Investigator: Wiebren A.A. Tjalma, MD, PhD, University Hospital of Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2026

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

October 21, 2026

First Submitted That Met QC Criteria

October 21, 2026

First Posted (Actual)

October 28, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3002025000175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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