Ovarian CancerDISARM CSANCT07809659
CanRisk-Based Ovarian Cancer Risk Assessment Versus Standard Practice (DISARM CSA)
A study testing CanRisk and Standard clinical risk assessment in people with Ovarian Cancer, run by Instituto Portugues Oncologia de Lisboa Francisco Gentil at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- CanRisk and Standard clinical risk assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,130 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 6 Aug 2026to Sep 2028
- Phase
- Interventional
- 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 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women, trans men, non-binary people with female reproductive organs
- Aged 18 to 75 years
- 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
- Able to give informed consent
- Expected to remain in the study catchment area for the duration of follow-up.
Who cannot join
- Personal history of cancer
- Previously undergone Risk-Reducing Salpingo-Oophorectomy (RRSO)
- Previously undergone multifactorial risk assessment (using CanRisk or another tool) incorporating risk factors, family history and genetic testing (panel +/- PGS)
- 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
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 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, +302132162845, mlionto@med.uoa.gr
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, 1099-023
Fatima VAZ, +351217229800, fvaz@ipolisboa.min-saude.pt
Ines Carvalho
About this study
Official title: Operationalising Multifactorial Ovarian Cancer Risk Assessment Using the CanRisk Tool Versus Standard Practices.
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.
Read more
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.
- Conditions
- Ovarian Cancer
- Being tested
- CanRisk, Standard clinical risk assessment
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanRiskOther
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.
Standard clinical risk assessmentOther
Standard clinical genetic counselling, genetic testing and risk assessment according to national clinical practice, without use of the CanRisk tool.
| Study group | Role | What they receive |
|---|---|---|
| CanRisk Intervention | Experimental | 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. Receives: Other: CanRisk |
| Standard Care | Active comparator | Participants receive standard clinical genetic assessment and management according to national clinical practice without CanRisk-guided risk estimation Receives: Other: Standard clinical risk assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Proportion of eligible individuals who consent to enroll in the study.
Measured: Month 12
Retention Rate
Proportion of enrolled participants who complete the study through final assessment.
Measured: Month 12
CanRisk Data Completeness
Proportion of CanRisk assessments completed with full data entry.
Measured: Month 12
Time to Complete CanRisk Assessment vs. Standard Practice
Average time required to complete a CanRisk-based risk assessment compared with standard practice risk assessment.
Measured: Month 12
Consultation and Assessment Workflow Timelines
Time required for consultation and assessment workflow processes associated with the CanRisk-based assessment.
Measured: Month 12
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.
Measured: Month 6 & 12
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.
Measured: Month 12
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.
Measured: Month 6 &12
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.
Measured: Month 6 & 12
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.
Measured: Month 6 & 12
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.
Measured: Month 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.
Measured: Immediately following delivery of risk assessment results
Incremental Mean Cost per Participant
Incremental mean cost per participant at 12 months, including assessment-related and downstream care costs incurred within follow-up.
Measured: Month 12
Incremental Cost per Completed Risk Assessment
Incremental cost per completed CanRisk-based risk assessment.
Measured: Month 12
Incremental Quality-Adjusted Life Years (QALYs)
Incremental quality-adjusted life years accrued over 12 months, comparing CanRisk-based assessment to standard practice.
Measured: Month 12
Descriptive Subgroup Summaries of Costs and Outcomes
Descriptive summary of costs and outcomes across pre-specified subgroups.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start6 Aug 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Portugues Oncologia de Lisboa Francisco Gentil
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Fatima Vaz, Instituto Portugues Oncologia de Lisboa Francisco Gentil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809659
- Sponsor's protocol ID
- DISARM CSA
- Acronym
- DISARM CSA
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2026
- Last updated
- 29 Sep 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operationalising Multifactorial Ovarian Cancer Risk Assessment Using the CanRisk Tool Versus Standard Practices.
- ClinicalTrials.gov ID
- NCT07809659
- Acronym / sponsor ID
- DISARM CSA / DISARM CSA
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,130 participants (estimated)
- Lead sponsor
- Instituto Portugues Oncologia de Lisboa Francisco GentilUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 9 Sep 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.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CanRisk Intervention | Experimental | Other: CanRiskParticipants 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. |
| Standard Care | Active comparator | Other: Standard clinical risk assessmentParticipants receive standard clinical genetic assessment and management according to national clinical practice without CanRisk-guided risk estimation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women, trans men, non-binary people with female reproductive organs
- Aged 18 to 75 years
- 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
- Able to give informed consent
- Expected to remain in the study catchment area for the duration of follow-up.
Key exclusion criteria (4 listed)
- Personal history of cancer
- Previously undergone Risk-Reducing Salpingo-Oophorectomy (RRSO)
- Previously undergone multifactorial risk assessment (using CanRisk or another tool) incorporating risk factors, family history and genetic testing (panel +/- PGS)
- 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 |
|---|---|---|
| CanRiskRisk 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. | Other | CanRisk Intervention |
| Standard clinical risk assessmentStandard clinical genetic counselling, genetic testing and risk assessment according to national clinical practice, without use of the CanRisk tool. | Other | Standard Care |
Primary outcome
Recruitment Rate
Time frame: Month 12
Proportion of eligible individuals who consent to enroll in the study.
Retention Rate
Time frame: Month 12
Proportion of enrolled participants who complete the study through final assessment.
CanRisk Data Completeness
Time frame: Month 12
Proportion of CanRisk assessments completed with full data entry.
Time to Complete CanRisk Assessment vs. Standard Practice
Time frame: Month 12
Average time required to complete a CanRisk-based risk assessment compared with standard practice risk assessment.
Consultation and Assessment Workflow Timelines
Time frame: Month 12
Time required for consultation and assessment workflow processes associated with the CanRisk-based assessment.
Usability of CanRisk (System Usability Scale)
Time frame: Month 6 & 12
Usability of the CanRisk tool as rated by healthcare professionals using the System Usability Scale (SUS), assessed at mid-study and end of study.
Qualitative Implementation Assessment (CFIR)
Time frame: Month 12
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.
Acceptability by Healthcare Professionals (TFA Questionnaire)
Time frame: Month 6 &12
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.
HCP Satisfaction with CanRisk vs. Standard Practice
Time frame: Month 6 & 12
Proportion of healthcare professionals reporting satisfaction with CanRisk versus standard practice assessment, assessed at mid-study and end of study.
HCP Willingness to Continue Using CanRisk
Time frame: Month 6 & 12
Proportion of healthcare professionals indicating willingness to continue using CanRisk after study completion, assessed at mid-study and end of study.
Qualitative Feedback from Healthcare Professionals
Time frame: Month 12
Number and type of themes identified from focus groups and/or semi-structured interviews with healthcare professionals, at end of study.
Acceptability by Study Participants (TFA Questionnaire)
Time frame: Immediately following delivery of risk assessment results
Acceptability of risk assessment results among study participants, measured using the TFA Generic Questionnaire, administered immediately after delivery of results.
Incremental Mean Cost per Participant
Time frame: Month 12
Incremental mean cost per participant at 12 months, including assessment-related and downstream care costs incurred within follow-up.
Incremental Cost per Completed Risk Assessment
Time frame: Month 12
Incremental cost per completed CanRisk-based risk assessment.
Incremental Quality-Adjusted Life Years (QALYs)
Time frame: Month 12
Incremental quality-adjusted life years accrued over 12 months, comparing CanRisk-based assessment to standard practice.
Descriptive Subgroup Summaries of Costs and Outcomes
Time frame: Month 12
Descriptive summary of costs and outcomes across pre-specified subgroups.
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 29 Sep 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.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CanRisk and Standard clinical risk assessment in people with Ovarian Cancer, run by Instituto Portugues Oncologia de Lisboa Francisco Gentil at 6 sites in 4 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 5 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 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Czechia, Greece, Lithuania, Portugal. 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 Fatima VAZ (+351217229800, fvaz@ipolisboa.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Month 12). The study lists 16 primary outcomes in all. 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 29 Sep 2026.