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

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Other: CanRisk; Other: Standard clinical risk assessment

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 Type: Interventional
• Enrollment (Estimated): 2130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Recruiting
    • Dept of Clinical Therapeutics, Alexandra Hospital
    • Contact: Michael Liontos; Phone Number: +302132162845; Email: mlionto@med.uoa.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; Standard clinical genetic counselling, genetic testing and risk assessment according to national clinical practice, without use of the CanRisk tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate	Proportion of eligible individuals who consent to enroll in the study.	Month 12
Retention Rate	Proportion of enrolled participants who complete the study through final assessment.	Month 12
CanRisk Data Completeness	Proportion of CanRisk assessments completed with full data entry.	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.	Month 12
Consultation and Assessment Workflow Timelines	Time required for consultation and assessment workflow processes associated with the CanRisk-based assessment.	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.	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.	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.	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.	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.	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.	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.	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.	Month 12
Incremental Cost per Completed Risk Assessment	Incremental cost per completed CanRisk-based risk assessment.	Month 12
Incremental Quality-Adjusted Life Years (QALYs)	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	Descriptive summary of costs and outcomes across pre-specified subgroups.	Month 12

Collaborators and Investigators

• Sponsor: Instituto Portugues Oncologia de Lisboa Francisco Gentil
• Collaborators: European Commission

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 22, 2026
• First Submitted That Met QC Criteria: September 2, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms
• Other Study ID Numbers: DISARM CSA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No