ClinicalTrials.gg
RecruitingNCT07809659DISARM CSAUpdated Sep 29, 2026

CanRisk-Based Ovarian Cancer Risk Assessment Versus Standard Practice (DISARM CSA)

An interventional study of CanRisk and Standard clinical risk assessment in Ovarian Cancer, sponsored by Instituto Portugues Oncologia de Lisboa Francisco Gentil. Recruiting at 6 sites in 4 countries. Open to female participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Instituto Portugues Oncologia de Lisboa Francisco Gentil · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Updated Sep 29, 2026First sites in Czechia, Lithuania and PortugalStudy contact changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
2,130
Allocation
Randomized
Ages
18 Years to 75 Years
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.

Planned enrollment
Largest of 53
2,130 · median 406
Started
2026
with 2 others
No phase
6 of 62
1 open now
Primary completion
2028-09
later than 14 of 22 live
Registered
62nd of 62
by date

Among the 62 studies in Ovarian Neoplasms with a site in Czechia, this one has the largest planned enrollment of the 53 interventional ones that give a count, is one of 3 that started in 2026, is one of 6 with no phase, reaches primary completion later than 14 of the 22 other live ones, and was the 62nd 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: 18 Years to 75 Years · 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

The purpose of this study is to improve how the risk of developing ovarian cancer is assessed in people who may be at increased risk of ovarian cancer due to their family history or genetic background.

In current clinical practice, ovarian cancer risk assessment usually relies on information about cancer in the family and, in some cases, genetic testing for certain genes known to be associated with ovarian cancer. While this approach is commonly used, the inclusion of additional factors may support more personalised ovarian cancer risk assessment.

This study compares two approaches to ovarian cancer risk assessment:

  • Standard clinical practice, which follows current national guidelines, and
  • A more personalised risk assessment, which uses a validated tool called CanRisk, recommended by European guidelines, to combine family history, genetic test results, and other factors, including health and lifestyle-related factors.

By comparing these two approaches, the study aims to understand whether the personalised risk assessment tool, CanRisk, can be used in everyday clinical care. To do this, researchers will investigate whether the CanRisk tool is feasible in clinical practice, acceptable to both healthcare professionals and persons receiving a risk assessment, as well as whether it can be delivered in a cost-effective way.

The study does not involve people who have been diagnosed with ovarian cancer. It focuses on individuals who are currently cancer-free and are undergoing assessment because they may have an increased risk of ovarian cancer.

Read the detailed description

Ovarian cancer (OC) is one of the leading causes of gynaecological cancer mortality in Europe, largely due to late diagnosis and the absence of effective population-level screening. Identifying women at increased risk is therefore essential to enable targeted prevention and early detection strategies. The CanRisk tool is a CE-marked multifactorial risk prediction tool that integrates family history, genetic and non-genetic factors to provide personalised risk estimates. While the tool has been validated extensively and is endorsed by international and European guidelines, the collection of data on its real-world feasibility, acceptability, and cost-effectiveness could enhance adoption in routine clinical practice. The CSA study contributes to this goal by comparing CanRisk-based risk assessment with standard practice across clinical sites in four European countries, generating key evidence for future implementation of precision prevention approaches in OC. The DISARM Clinical Study A (CSA) is a multisite, multi-country, non-commercial, low interventional randomised controlled study designed to evaluate the implementation of multifactorial ovarian cancer risk assessment using the CanRisk tool compared with standard practice. The study aims to assess the feasibility, acceptability and cost-effectiveness of CanRisk-based ovarian cancer risk assessment across clinical sites in Greece, Portugal, the Czech Republic and Lithuania.

03

Conditions studied

  • Ovarian Cancer

Browse trials for

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

  1. Women, trans men, non-binary people with female reproductive organs
  2. Aged 18 to 75 years
  3. Referred or self-referred because of a family history suggestive of increased risk for ovarian, fallopian tube or peritoneum cancer, or because a family member has been found to have a PV associated with OC risk
  4. Able to give
  5. Expected to remain in the study catchment area for the duration of follow-up.

Exclusion criteria

Exclusion Criteria:

  1. Personal history of cancer
  2. Previously undergone Risk-Reducing Salpingo-Oophorectomy (RRSO)
  3. Previously undergone multifactorial risk assessment (using CanRisk or another tool) incorporating risk factors, family history and genetic testing (panel +/- PGS)
  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(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,130 participants (estimated)

Study arms

  • Experimental
    CanRisk Intervention

    Participants receive ovarian cancer risk assessment using the CanRisk tool incorporating personal and family history, genetic testing results, and a polygenic risk score (PRS), in addition to standard clinical management.

    Other: CanRisk

  • Active comparator
    Standard Care

    Participants receive standard clinical genetic assessment and management according to national clinical practice without CanRisk-guided risk estimation

    Other: Standard clinical risk assessment

Interventions

  • OtherCanRisk

    Risk assessment using the CanRisk tool, incorporating personal and family history, genetic testing results and polygenic risk score (PRS), to provide individualized ovarian cancer risk estimation.

  • OtherStandard clinical risk assessment

    Standard clinical genetic counselling, genetic testing and risk assessment according to national clinical practice, without use of the CanRisk tool.

06

What researchers measure

Primary outcomes

  1. Recruitment Rate

    Proportion of eligible individuals who consent to enroll in the study.

    Time frame: Month 12

  2. Retention Rate

    Proportion of enrolled participants who complete the study through final assessment.

    Time frame: Month 12

  3. CanRisk Data Completeness

    Proportion of CanRisk assessments completed with full data entry.

    Time frame: Month 12

  4. Time to Complete CanRisk Assessment vs. Standard Practice

    Average time required to complete a CanRisk-based risk assessment compared with standard practice risk assessment.

    Time frame: Month 12

  5. Consultation and Assessment Workflow Timelines

    Time required for consultation and assessment workflow processes associated with the CanRisk-based assessment.

    Time frame: Month 12

  6. Usability of CanRisk (System Usability Scale)

    Usability of the CanRisk tool as rated by healthcare professionals using the System Usability Scale (SUS), assessed at mid-study and end of study.

    Time frame: Month 6 & 12

  7. Qualitative Implementation Assessment (CFIR)

    Number and type of implementation barriers and facilitators identified through qualitative assessment guided by the Consolidated Framework for Implementation Research (CFIR), at end of study.

    Time frame: Month 12

  8. Acceptability by Healthcare Professionals (TFA Questionnaire)

    Acceptability of CanRisk-based assessment among healthcare professionals, measured using the Theoretical Framework of Acceptability (TFA) Generic Questionnaire, assessed at mid-study and end of study.

    Time frame: Month 6 &12

  9. HCP Satisfaction with CanRisk vs. Standard Practice

    Proportion of healthcare professionals reporting satisfaction with CanRisk versus standard practice assessment, assessed at mid-study and end of study.

    Time frame: Month 6 & 12

  10. HCP Willingness to Continue Using CanRisk

    Proportion of healthcare professionals indicating willingness to continue using CanRisk after study completion, assessed at mid-study and end of study.

    Time frame: Month 6 & 12

  11. Qualitative Feedback from Healthcare Professionals

    Number and type of themes identified from focus groups and/or semi-structured interviews with healthcare professionals, at end of study.

    Time frame: Month 12

  12. Acceptability by Study Participants (TFA Questionnaire)

    Acceptability of risk assessment results among study participants, measured using the TFA Generic Questionnaire, administered immediately after delivery of results.

    Time frame: Immediately following delivery of risk assessment results

  13. Incremental Mean Cost per Participant

    Incremental mean cost per participant at 12 months, including assessment-related and downstream care costs incurred within follow-up.

    Time frame: Month 12

  14. Incremental Cost per Completed Risk Assessment

    Incremental cost per completed CanRisk-based risk assessment.

    Time frame: Month 12

  15. Incremental Quality-Adjusted Life Years (QALYs)

    Incremental quality-adjusted life years accrued over 12 months, comparing CanRisk-based assessment to standard practice.

    Time frame: Month 12

  16. Descriptive Subgroup Summaries of Costs and Outcomes

    Descriptive summary of costs and outcomes across pre-specified subgroups.

    Time frame: Month 12

07

Study locations

5 of 6 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar 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 Sep 2028, 25 months after the start.

Of 282 non-industry interventional studies with no phase under Ovarian Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 76. This study's planned 25 months is below that.

Counting every sponsor, half of 293 studies reached it within 46 months; a quarter within 23 and three quarters within 76.

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

Registered
Jul 22, 2026
First posted
Sep 9, 2026
StartActual
Aug 6, 2026
Primary completionEst.
Sep 2028
CompletionEst.
Sep 2028
Last update
Sep 29, 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.
Sites
5 sites added — first sites in Czechia, Lithuania and Portugal
Show 5 added (2 Czechia, 1 Greece, 1 Lithuania, 1 Portugal)
  • Vseobecna Fakultni Nemocnice V Praze · Prague, Czechia
  • Fakultni Nemocnice Bulovka · Prague, Czechia
  • National Centre for Scientific Research Demokritos · Athens, Greece
  • Lithuanian University of Health Sciences · Kaunas, Lithuania
  • Instituto Português de Oncologia de Lisboa Francisco Gentil E.P.E. · Lisbon, Portugal
Sep 29, 2026
Contact
Study contact now listed: added f•••@ipolisboa.min-saude.pt · •••9800. See the current contact
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    5 sites added — first sites in Czechia, Lithuania and Portugal
    Show 5 added (2 Czechia, 1 Greece, 1 Lithuania, 1 Portugal)
    • Vseobecna Fakultni Nemocnice V Praze · Prague, Czechia
    • Fakultni Nemocnice Bulovka · Prague, Czechia
    • National Centre for Scientific Research Demokritos · Athens, Greece
    • Lithuanian University of Health Sciences · Kaunas, Lithuania
    • Instituto Português de Oncologia de Lisboa Francisco Gentil E.P.E. · Lisbon, Portugal
    Contact Study contact now listed: added f•••@ipolisboa.min-saude.pt · •••9800. See the current contact

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
NCT07809659
Lead sponsor
Instituto Portugues Oncologia de Lisboa Francisco Gentil
Collaborators
European Commission
Responsible party
Fatima Vaz (Fátima VAZ, Senior Consultant Medical Oncology, Instituto Portugues Oncologia de Lisboa Francisco Gentil) — Principal investigator
First posted
Sep 9, 2026
Start date
Aug 6, 2026
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Fatima VAZ
Contact
fvaz@ipolisboa.min-saude.pt
+351217229800

Oversight

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

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