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

RecruitingNAAges 18 Years - anyFemaleUniversiteit Antwerpen
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 * Participant has severe anemia * Participant received a blood transfusion two weeks before sample collection
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What it tests

  • Colli-Pee 20 mL device with UCM
  • Evalyn Brush
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Where

1 site
University Hospital of Antwerp (UZA)
Edegem, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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