ClinicalTrials.gg
RecruitingNCT07693894DISARM CSBUpdated Oct 1, 2026

Innovative Ovarian Cancer Biomarker Assays

An observational study in Ovarian Cancer, sponsored by National and Kapodistrian University of Athens. Recruiting at 7 sites in 5 countries. Open to female participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by National and Kapodistrian University of Athens · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Updated Oct 1, 2026Now RecruitingFirst sites in 5 new countries+3 moreGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,080
Ages
35 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 62 studies in Ovarian Neoplasms with a site in Czechia — 13 open to participants now, 23 under way, 12 of them phase 3. Ovarian Neoplasms · Czechia.

Started
2026
with 2 others
Observational
8 of 62
4 open now
Primary completion
2028-12
later than 17 of 22 live
Registered
61st of 62
by date

Among the 62 studies in Ovarian Neoplasms with a site in Czechia, this one is one of 3 that started in 2026, is one of 8 observational ones, reaches primary completion later than 17 of the 22 other live ones, and was the 61st registered.

Ovarian Neoplasms

3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

13 of the 62 studies in Ovarian Neoplasms with a site in Czechia are open now. Recruiting first, the newest first:

7 more — sign in →

All 13 open studies →

A study can be open while its sites in Czechia have not opened yet or have stopped. Only those recruiting at a site in Czechia →

Who these studies take

Of the 606 Ovarian Neoplasms studies recruiting now, 443 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 35 Years and older · female · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 62 studies in Ovarian Neoplasms with a site in Czechia, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Ovarian Cancer

Browse trials for

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

EOC patients

  1. Women, trans men and non-binary people with female reproductive organs
  2. Aged ≥35 years*
  3. diagnosed, by , 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

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

Exclusion Criteria:

  1. Prior history and any treatment for
  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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,080 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Diagnostic testInvestigational ovarian cancer biomarker assays

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

06

What researchers measure

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.

    Time frame: Baseline

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

07

Study locations

6 of 7 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Dec 2028, 28 months after the start.

Of 216 non-industry observational studies under Ovarian Neoplasms, half reached primary completion within 71 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 206. This study's planned 28 months is below that.

Counting every sponsor, half of 268 studies reached it within 61 months; a quarter within 35 and three quarters within 185.

Start moved once since we started tracking on Sep 25, 2026: Jul 2026 → Aug 2026, on Oct 1, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 5, 2026
First posted
Jul 9, 2026
StartActual
Aug 3, 2026was Jul 2026
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 1, 2026
Sites
7 sites added — first sites in Czechia, Greece, Lithuania, Portugal and United Kingdom
Show 7 added (2 Czechia, 2 Greece, 1 Lithuania, 1 Portugal, 1 United Kingdom)
  • Vseobecna Fakultni Nemocnice V Praze · Prague, Czechia
  • Fakultni Nemocnice Bulovka · Prague, Czechia
  • National Centre for Scientific Research Demokritos · Athens, Greece
  • Dept of Clinical Therapeutics, Alexandra Hospital · Athens, Greece
  • Lithuanian University of Health Sciences · Kaunas, Lithuania
  • Instituto Português de Oncologia de Lisboa Francisco Gentil E.P.E. · Lisbon, Portugal
  • Imperial College Healthcare NHS Trust Hammersmith Hospital · London, United Kingdom
Oct 1, 2026
Start date
Jul 2026→Aug 3, 2026 (actual)
Oct 1, 2026
Title
DISARM Clinical Study B: Evaluation of Innovative Ovarian Cancer Biomarker Assays
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Not yet recruiting→Recruiting
    7 sites added — first sites in Czechia, Greece, Lithuania, Portugal and United Kingdom
    Show 7 added (2 Czechia, 2 Greece, 1 Lithuania, 1 Portugal, 1 United Kingdom)
    • Vseobecna Fakultni Nemocnice V Praze · Prague, Czechia
    • Fakultni Nemocnice Bulovka · Prague, Czechia
    • National Centre for Scientific Research Demokritos · Athens, Greece
    • Dept of Clinical Therapeutics, Alexandra Hospital · Athens, Greece
    • Lithuanian University of Health Sciences · Kaunas, Lithuania
    • Instituto Português de Oncologia de Lisboa Francisco Gentil E.P.E. · Lisbon, Portugal
    • Imperial College Healthcare NHS Trust Hammersmith Hospital · London, United Kingdom
    Start date Jul 2026→Aug 3, 2026 (now actual)
    Title DISARM Clinical Study B: Evaluation of Innovative Ovarian Cancer Biomarker Assays
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07693894
Collaborators
European Commission
Responsible party
Michael Liontos (Assistant Professor of Medical Oncology, National and Kapodistrian University of Athens) — Principal investigator
First posted
Jul 9, 2026
Start date
Aug 3, 2026
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Oct 1, 2026

Study contacts

Michael Liontos
Contact
mlionto@med.uoa.gr
+302132162845

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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