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

NCT07693894 | Not Yet Recruiting

• 2 other identifiers: DISARM CSB101214318
• Study Type: observational
• Target: 2,080
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (4)

• To evaluate the discriminatory ability of OVA-Multimodal in distinguishing EOC from non-cancer

  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.

  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.

  Baseline (single study visit)

• To explore and quantify associations between candidate risk factors and EOC case status by comparing EOC cases with healthy controls.

  Baseline (single study visit)

Study Arms (2)

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.

Diagnostic Test: Investigational ovarian cancer biomarker assays

Healthy controls

Healthy controls without a cancer diagnosis recruited for comparison with participants with epithelial ovarian cancer.

Diagnostic Test: Investigational ovarian cancer biomarker assays

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).

Epithelial Ovarian Cancer; Healthy controls

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• European Commission: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (whole blood, plasma and serum) collected from women with epithelial ovarian cancer and healthy controls for analysis of investigational ovarian cancer biomarker assays, including glycans/glycoproteins (OVA-GLY), volatile organic compounds (OVA-VOC), circulating miRNAs (OVA-miRNA), and related analyses

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medical Oncology

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 9, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07