Operationalising Multifactorial Ovarian Cancer Risk Assessment Using the CanRisk Tool Versus Standard Practices.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,130
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: CanRisk (Other)
Standard Care
Participants receive standard clinical genetic assessment and management according to national clinical practice without CanRisk-guided risk estimation
干预措施: Standard clinical risk assessment (Other)
结局指标
主要结局
Recruitment Rate
时间窗: Month 12
Proportion of eligible individuals who consent to enroll in the study.
Retention Rate
时间窗: Month 12
Proportion of enrolled participants who complete the study through final assessment.
CanRisk Data Completeness
时间窗: Month 12
Proportion of CanRisk assessments completed with full data entry.
Time to Complete CanRisk Assessment vs. Standard Practice
时间窗: Month 12
Average time required to complete a CanRisk-based risk assessment compared with standard practice risk assessment.
Consultation and Assessment Workflow Timelines
时间窗: Month 12
Time required for consultation and assessment workflow processes associated with the CanRisk-based assessment.
Usability of CanRisk (System Usability Scale)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: Month 12
Incremental cost per completed CanRisk-based risk assessment.
Incremental Quality-Adjusted Life Years (QALYs)
时间窗: 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
时间窗: Month 12
Descriptive summary of costs and outcomes across pre-specified subgroups.
次要结局
未报告次要终点
研究者
Fatima Vaz
Fátima VAZ, Senior Consultant Medical Oncology
Instituto Portugues Oncologia de Lisboa Francisco Gentil