Methylation markers in self-samples to help detect gynecological cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MYSSELF study investigates (epi)genetic biomarkers in self-collected samples, such as first-void urine and vaginal swabs, to see if they correlate with gynecological cancers or postmenopausal bleeding. Participants include individuals with diagnosed cancers or precursor conditions, as well as those with postmenopausal bleeding, and samples from self-collection, clinician collection, and blood are analyzed as part of standard diagnostic workups. No additional invasive procedures are required beyond routine care, and tissue samples are used only if already being collected. The goal is to identify less invasive markers that could enable earlier, more specific detection in the future.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Wiebren A.A. Tjalma, MD, PhD — University Hospital of Antwerp
• Study coordinator: Tine Pinxteren, MSc
• Email: tine.pinxteren@uantwerpen.be
• Phone: 476014843

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Radiotherapy for gynecologic cancer with up to 10 metastatic sites

  This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość · NCT07883798

• Testing trastuzumab deruxtecan (T‑DxD) for HER2‑positive advanced solid tumors

  This will test whether trastuzumab deruxtecan (T‑DxD) helps adults in the US with HER2‑positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have had prior systemic treatment and have no satisfactory alternative options.

  Recruiting at 18 sites AstraZeneca · Birmingham, Alabama and 17 other locations · NCT07124000

• Using Belzutifan to treat recurrent clear cell ovarian carcinoma

  This study is testing if a new targeted therapy called Belzutifan can help people with recurrent clear cell ovarian cancer feel better and manage their disease.

  Recruiting at 2 sites Phase 2 Dana-Farber Cancer Institute · Boston, Massachusetts and 1 other locations · NCT06677190

• Collecting specimens and data for early detection and prevention of ovarian cancer

  This study is trying to find better ways to detect and prevent ovarian cancer early by collecting blood and tissue samples from people at high risk.

  Recruiting Northwestern University · Chicago, Illinois · NCT00005095

• Analyzing shopping habits to improve early cancer diagnosis

  This study is trying to see if changes in shopping habits can help spot cancer earlier by looking at purchase data from loyalty cards of people recently diagnosed with cancer and those without it.

  Recruiting Imperial College London · London · NCT06447064

• Biobank for studying ALS and Alzheimer's diseases

  This study is collecting blood, skin samples, and health information from people to see how genetics might help us understand and find treatments for ALS and Alzheimer's disease.

  Recruiting New York Stem Cell Foundation Research Institute · New York, New York · NCT06203106

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.