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NCT Number: NCT07809659

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Clinical Therapeutics, Alexandra Hospital

Athens, Greece

Location status: Recruiting

Location contact

Michael Liontos

CONTACT

[email protected]

+302132162845

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

CanRisk

Other

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 assessment

Other

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

Primary outcomes

  1. Recruitment Rate

    Time frame: Month 12

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

  2. Retention Rate

    Time frame: Month 12

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

  3. CanRisk Data Completeness

    Time frame: Month 12

    Proportion of CanRisk assessments completed with full data entry.

  4. 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.

  5. Consultation and Assessment Workflow Timelines

    Time frame: Month 12

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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. Incremental Cost per Completed Risk Assessment

    Time frame: Month 12

    Incremental cost per completed CanRisk-based risk assessment.

  15. 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.

  16. Descriptive Subgroup Summaries of Costs and Outcomes

    Time frame: Month 12

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

Sponsors and collaborators

Lead sponsor

Instituto Portugues Oncologia de Lisboa Francisco Gentil

Other

Collaborators

  • European Commission

Registry information

Official study title

Operationalising Multifactorial Ovarian Cancer Risk Assessment Using the CanRisk Tool Versus Standard Practices.

Acronym: DISARM CSA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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