Innovative Ovarian Cancer Biomarker Assays

ConditionOvarian Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age35+

SponsorNational and Kapodistrian University of Athens

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

The study population consists of women, trans men and non-binary people with female reproductive organs aged 35 years or older. Participants include individuals with pathologically confirmed epithelial ovarian cancer (EOC) prior to surgical intervention or treatment and healthy controls without a history of cancer

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

2,080 Participants

are divided into 2 treatment groups

Group A: Epithelial Ovarian Cancer1 intervention

Group B: Healthy controls1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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)