DISARM Clinical Study B: Evaluation of Innovative Ovarian Cancer Biomarker Assays

Sponsor
National and Kapodistrian University of Athens
Study ID
NCT07693894
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
35 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Investigational ovarian cancer biomarker assays — DIAGNOSTIC_TEST
    Collection of blood samples for investigational ovarian cancer biomarker analyses (OVA-GLY, OVA-VOC and OVA-miRNA).

Study Details

Ovarian cancer is often diagnosed at a later stage because early symptoms can be mild or non-specific. Earlier detection of ovarian cancer could improve treatment options and outcomes. Recent research has focused on the development of blood-based tests, sometimes referred to as liquid biopsy tests, which aim to look for changes in the blood that could be linked to cancer. These tests are still under investigation and are not part of routine clinical care. The purpose of this study is to evaluate several blood-based ovarian cancer tests. This will be done by comparing test results from people who have ovarian cancer with results from people who do not have cancer. The study will also collect information from standard blood tests and genetic analyses to better understand how these results relate to ovarian cancer. This study is for research purposes only. The blood-based tests being evaluated are investigational and are not used to make medical decisions or diagnoses for women taking part in the study.

Key Dates

First listed
Jul 9, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
2,080 participants (estimated)

Arms

  • Arm: Epithelial Ovarian Cancer
    Women with epithelial ovarian cancer prior to surgical intervention or treatment. Participants present with an adnexal mass suspicious of ovarian cancer and are subsequently classified based on histopathological diagnosis.
  • Arm: Healthy controls
    Healthy controls without a cancer diagnosis recruited for comparison with participants with epithelial ovarian cancer.

Primary Outcome Measure

To evaluate the discriminatory abilities of the individual biomarker assays (OVA-GLY, OVA-VOC, OVA-miRNA) in distinguishing EOC from non-cancer. [ Time Frame: Baseline ]

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