DISARM Clinical Study B: Evaluation of Innovative Ovarian Cancer Biomarker Assays
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Investigational ovarian cancer biomarker assays.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: from 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multi-site, Multi-country Evaluation of Innovative Ovarian Cancer Biomarker Assays. (DISARM Clinical Study B-CSB)
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test Investigational ovarian cancer biomarker assays
Collection of blood samples for investigational ovarian cancer biomarker analyses (OVA-GLY, OVA-VOC and OVA-miRNA).
Primary outcome measures
- 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]
Secondary outcome measures (4)
- To evaluate the discriminatory ability of OVA-Multimodal in distinguishing EOC 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. [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. [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. [Time frame: Baseline (single study visit)]
Eligibility criteria
Inclusion criteria
EOC patients
- Women, trans men and non-binary people with female reproductive organs
- Aged ≥35 years\*
- Pathologically diagnosed, by biopsy, with EOC prior to surgical intervention or treatment
- Presenting with adnexal mass suspicious of OC on imaging and scheduled for surgical resection or biopsy (and subsequent confirmation of EOC)
- Able to give informed consent
Healthy controls
- Women, trans men and non-binary people with female reproductive organs
- Aged ≥35 years
- No cancer history
- Able to give informed consent
Exclusion criteria
- Prior history and any treatment for malignancy
- Prior removal of either ovary for any reason
- Pregnant or lactating
- Any condition or circumstance that, in the opinion of the investigator, could interfere with the participant's ability to participate or comply with study requirements
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07693894 · DISARM CSB · 101214318