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.
The DISARM Clinical Study B (CSB) is a multisite, multi-country, non-commercial, minimal risk, exploratory research study with a case-control design. The study aims to evaluate the discriminatory abilities of innovative liquid biopsy biomarker assays for ovarian cancer, including glycans/glycoproteins (OVA-GLY), volatile organic compounds (OVA-VOC), and circulating miRNAs (OVA-miRNAs). Primary endpoints are the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of the investigational biomarker assays. Women with epithelial ovarian cancer (EOC) before treatment and healthy controls (participants without cancer diagnosis) will be recruited across participating European clinical sites. Subjects presenting with adnexal masses suspicious of ovarian cancer will be enrolled and tested before surgery and retrospectively classified according to histopathological findings. No randomisation, blinding, or interventional procedures are foreseen. The only study-specific procedure is the minimally invasive collection of blood samples.
Study Type
OBSERVATIONAL
Enrollment
2,080
Collection of blood samples for investigational ovarian cancer biomarker analyses (OVA-GLY, OVA-VOC and OVA-miRNA).
To evaluate the discriminatory abilities of the individual biomarker assays (OVA-GLY, OVA-VOC, OVA-miRNA) in distinguishing EOC from non-cancer.
Area under the receiver operating characteristic curve (AUC), sensitivity and specificity of each individual biomarker assay (OVA-GLY, OVA-VOC and OVA-miRNA) in distinguishing epithelial ovarian cancer from non-cancer.
Time frame: Baseline
To evaluate the discriminatory ability of OVA-Multimodal in distinguishing EOC from non-cancer
Area under the receiver operating characteristic curve (AUC), sensitivity and specificity of OVA-Multimodal in distinguishing epithelial ovarian cancer from non-cancer.
Time frame: Baseline (single study visit)
To evaluate the discriminatory abilities of the individual biomarker assays (OVA-GLY, OVA-VOC, OVA-miRNA) and OVA-Multimodal in comparison to CA-125.
Area under the receiver operating characteristic curve (AUC), sensitivity and specificity of OVA-GLY, OVA-VOC, OVA-miRNA and OVA-Multimodal compared with CA-125.
Time frame: Baseline (single study visit)
To estimate the cost-effectiveness of the DISARM assays versus CA-125 under defined clinical-use scenarios using model-based early economic evaluation and study-based resource use and cost data.
Incremental cost per additional ovarian cancer detected; incremental cost per 10,000 women (budget impact); exploratory incremental cost per life-year gained (LYG); and incremental cost per quality-adjusted life year (QALY) gained.
Time frame: Baseline (single study visit)
To explore and quantify associations between candidate risk factors and EOC case status by comparing EOC cases with healthy controls.
Differences in prevalence or means of candidate risk factors between epithelial ovarian cancer cases and healthy controls and odds ratios (95% confidence interval) for candidate risk factors associated with case status.
Time frame: Baseline (single study visit)
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