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

2 september 2026 bijgewerkt door: Fatima Vaz, Instituto Portugues Oncologia de Lisboa Francisco Gentil

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.

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

2130

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Griekenland
      • Athens, Griekenland
        • Werving
        • Dept of Clinical Therapeutics, Alexandra Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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 informed consent
  5. Expected to remain in the study catchment area for the duration of follow-up.

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: CanRisk
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.
Actieve vergelijker: Standard Care
Participants receive standard clinical genetic assessment and management according to national clinical practice without CanRisk-guided risk estimation
Ander: Standard clinical risk assessment
Standard clinical genetic counselling, genetic testing and risk assessment according to national clinical practice, without use of the CanRisk tool.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recruitment Rate
Tijdsspanne: Month 12
Proportion of eligible individuals who consent to enroll in the study.
Month 12
Retention Rate
Tijdsspanne: Month 12
Proportion of enrolled participants who complete the study through final assessment.
Month 12
CanRisk Data Completeness
Tijdsspanne: Month 12
Proportion of CanRisk assessments completed with full data entry.
Month 12
Time to Complete CanRisk Assessment vs. Standard Practice
Tijdsspanne: Month 12
Average time required to complete a CanRisk-based risk assessment compared with standard practice risk assessment.
Month 12
Consultation and Assessment Workflow Timelines
Tijdsspanne: Month 12
Time required for consultation and assessment workflow processes associated with the CanRisk-based assessment.
Month 12
Usability of CanRisk (System Usability Scale)
Tijdsspanne: 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.
Month 6 & 12
Qualitative Implementation Assessment (CFIR)
Tijdsspanne: 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.
Month 12
Acceptability by Healthcare Professionals (TFA Questionnaire)
Tijdsspanne: 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.
Month 6 &12
HCP Satisfaction with CanRisk vs. Standard Practice
Tijdsspanne: Month 6 & 12
Proportion of healthcare professionals reporting satisfaction with CanRisk versus standard practice assessment, assessed at mid-study and end of study.
Month 6 & 12
HCP Willingness to Continue Using CanRisk
Tijdsspanne: Month 6 & 12
Proportion of healthcare professionals indicating willingness to continue using CanRisk after study completion, assessed at mid-study and end of study.
Month 6 & 12
Qualitative Feedback from Healthcare Professionals
Tijdsspanne: Month 12
Number and type of themes identified from focus groups and/or semi-structured interviews with healthcare professionals, at end of study.
Month 12
Acceptability by Study Participants (TFA Questionnaire)
Tijdsspanne: 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.
Immediately following delivery of risk assessment results
Incremental Mean Cost per Participant
Tijdsspanne: Month 12
Incremental mean cost per participant at 12 months, including assessment-related and downstream care costs incurred within follow-up.
Month 12
Incremental Cost per Completed Risk Assessment
Tijdsspanne: Month 12
Incremental cost per completed CanRisk-based risk assessment.
Month 12
Incremental Quality-Adjusted Life Years (QALYs)
Tijdsspanne: Month 12
Incremental quality-adjusted life years accrued over 12 months, comparing CanRisk-based assessment to standard practice.
Month 12
Descriptive Subgroup Summaries of Costs and Outcomes
Tijdsspanne: Month 12
Descriptive summary of costs and outcomes across pre-specified subgroups.
Month 12

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Instituto Portugues Oncologia de Lisboa Francisco Gentil

Medewerkers

European Commission

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 augustus 2026

Primaire voltooiing (Geschat)

1 september 2028

Studie voltooiing (Geschat)

1 september 2028

Studieregistratiedata

Eerst ingediend

22 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 september 2026

Eerst geplaatst (Werkelijk)

9 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 september 2026

Laatste update ingediend die voldeed aan QC-criteria

2 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DISARM CSA

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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