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

Multi-site, Multi-country Evaluation of Innovative Ovarian Cancer Biomarker Assays. (DISARM Clinical Study B-CSB)

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.

Inclusion Criteria:

EOC patients

1. Women, trans men and non-binary people with female reproductive organs
2. Aged ≥35 years*
3. Pathologically diagnosed, by biopsy, with EOC prior to surgical intervention or treatment
4. Presenting with adnexal mass suspicious of OC on imaging and scheduled for surgical resection or biopsy (and subsequent confirmation of EOC)
5. Able to give informed consent

Healthy controls

1. Women, trans men and non-binary people with female reproductive organs
2. Aged ≥35 years
3. No cancer history
4. Able to give informed consent

Exclusion Criteria:

1. Prior history and any treatment for malignancy
2. Prior removal of either ovary for any reason
3. Pregnant or lactating
4. 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