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

2 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

2130

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Grèce
      • Athens, Grèce
        • Recrutement
        • Dept of Clinical Therapeutics, Alexandra Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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.
Comparateur actif: Standard Care
Participants receive standard clinical genetic assessment and management according to national clinical practice without CanRisk-guided risk estimation
Autre: Standard clinical risk assessment
Standard clinical genetic counselling, genetic testing and risk assessment according to national clinical practice, without use of the CanRisk tool.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Recruitment Rate
Délai: Month 12
Proportion of eligible individuals who consent to enroll in the study.
Month 12
Retention Rate
Délai: Month 12
Proportion of enrolled participants who complete the study through final assessment.
Month 12
CanRisk Data Completeness
Délai: Month 12
Proportion of CanRisk assessments completed with full data entry.
Month 12
Time to Complete CanRisk Assessment vs. Standard Practice
Délai: 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
Délai: Month 12
Time required for consultation and assessment workflow processes associated with the CanRisk-based assessment.
Month 12
Usability of CanRisk (System Usability Scale)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: Month 12
Incremental cost per completed CanRisk-based risk assessment.
Month 12
Incremental Quality-Adjusted Life Years (QALYs)
Délai: 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
Délai: Month 12
Descriptive summary of costs and outcomes across pre-specified subgroups.
Month 12

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Instituto Portugues Oncologia de Lisboa Francisco Gentil

Collaborateurs

European Commission

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

6 août 2026

Achèvement primaire (Estimé)

1 septembre 2028

Achèvement de l'étude (Estimé)

1 septembre 2028

Dates d'inscription aux études

Première soumission

22 juillet 2026

Première soumission répondant aux critères de contrôle qualité

2 septembre 2026

Première publication (Réel)

9 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • DISARM CSA

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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