Ovarian CancerDISARM CSBNCT07693894
Innovative Ovarian Cancer Biomarker Assays
An observational study of Ovarian Cancer, run by National and Kapodistrian University of Athens at 7 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Investigational ovarian cancer biomarker assays
- How many people
- 2,080 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 3 Aug 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Show all 11Show fewer
- Healthy controls
- Women, trans men and non-binary people with female reproductive organs
- Aged ≥35 years
- No cancer history
- Able to give informed consent
Who cannot join
- 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 locations and contacts
7 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 5 countries
Czechia2 sites, 2 recruiting
- Recruiting
Vseobecna Fakultni Nemocnice V Praze
Prague, 12808
Michal Vočka, +420 224 962 219, Michal.Vocka@vfn.cz
Michal Vočka
- Recruiting
Fakultni Nemocnice Bulovka
Prague, 180000
Michal Zikán, +420 26608 3202, michal.zikan@bulovka.cz
Michal Zikán
Greece2 sites, 2 recruiting
- Recruiting
National Centre for Scientific Research Demokritos
Athens, Attica, 15341
Florentia Fostira, +302106503823, florentia_fostira@hotmail.com
Florentia Fostira
- Recruiting
Dept of Clinical Therapeutics, Alexandra Hospital
Athens
Michael Liontos, mlionto@med.uoa.gr
Michael Liontos
Lithuania1 site, 1 recruiting
- Not yet recruiting
Lithuanian University of Health Sciences
Kaunas
Daiva Vaitkienė, +37037326591, daiva.vaitkiene@kaunoklinikos.lt
Daiva Vaitkienė
Portugal1 site, 1 recruiting
- Recruiting
Instituto Português de Oncologia de Lisboa Francisco Gentil E.P.E.
Lisbon
Fatima VAZ, +351217229800, fvaz@ipolisboa.min-saude.pt
Lucia Correia
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust Hammersmith Hospital
London, W12 0HS
Christina Fotopoulou, 02033133274, c.fotopoulou@imperial.ac.uk
Christina Fotopoulou
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- Investigational ovarian cancer biomarker assays
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational ovarian cancer biomarker assaysDiagnostic test
Collection of blood samples for investigational ovarian cancer biomarker analyses (OVA-GLY, OVA-VOC and OVA-miRNA).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Investigational ovarian cancer biomarker assays | |
| Healthy controls | Healthy controls without a cancer diagnosis recruited for comparison with participants with epithelial ovarian cancer. Receives: Diagnostic Test: Investigational ovarian cancer biomarker assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start3 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Michael Liontos, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693894
- Sponsor's protocol ID
- DISARM CSB
- Other IDs
- 101214318
- Acronym
- DISARM CSB
- Status last verified
- Sep 2026
- First submitted
- 5 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site, Multi-country Evaluation of Innovative Ovarian Cancer Biomarker Assays. (DISARM Clinical Study B-CSB)
- ClinicalTrials.gov ID
- NCT07693894
- Acronym / sponsor ID
- DISARM CSB / DISARM CSB
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,080 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epithelial Ovarian Cancer | – | Diagnostic Test: Investigational ovarian cancer biomarker assaysWomen 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. |
| Healthy controls | – | Diagnostic Test: Investigational ovarian cancer biomarker assaysHealthy controls without a cancer diagnosis recruited for comparison with participants with epithelial ovarian cancer. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational ovarian cancer biomarker assaysCollection of blood samples for investigational ovarian cancer biomarker analyses (OVA-GLY, OVA-VOC and OVA-miRNA). | Diagnostic test | Epithelial Ovarian Cancer, Healthy controls |
Primary outcome
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
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by National and Kapodistrian University of Athens at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Czechia, Greece, Lithuania, Portugal, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Liontos (+302132162845, mlionto@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.