CanRisk-Based Ovarian Cancer Risk Assessment Versus Standard Practice (DISARM CSA) (DISARM CSA)
2026年9月2日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
2130
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Athens、希腊
- 招聘中
- Dept of Clinical Therapeutics, Alexandra Hospital
-
接触：
- Michael Liontos
- 电话号码：+302132162845
- 邮箱：mlionto@med.uoa.gr
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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.
|
|
有源比较器：Standard Care
Participants receive standard clinical genetic assessment and management according to national clinical practice without CanRisk-guided risk estimation
|
Standard clinical genetic counselling, genetic testing and risk assessment according to national clinical practice, without use of the CanRisk tool.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment Rate
大体时间：Month 12
|
Proportion of eligible individuals who consent to enroll in the study.
|
Month 12
|
|
Retention Rate
大体时间：Month 12
|
Proportion of enrolled participants who complete the study through final assessment.
|
Month 12
|
|
CanRisk Data Completeness
大体时间：Month 12
|
Proportion of CanRisk assessments completed with full data entry.
|
Month 12
|
|
Time to Complete CanRisk Assessment vs. Standard Practice
大体时间：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
大体时间：Month 12
|
Time required for consultation and assessment workflow processes associated with the CanRisk-based assessment.
|
Month 12
|
|
Usability of CanRisk (System Usability Scale)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：Month 12
|
Incremental cost per completed CanRisk-based risk assessment.
|
Month 12
|
|
Incremental Quality-Adjusted Life Years (QALYs)
大体时间：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
大体时间：Month 12
|
Descriptive summary of costs and outcomes across pre-specified subgroups.
|
Month 12
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月6日
初级完成 (估计的)
2028年9月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年7月22日
首先提交符合 QC 标准的
2026年9月2日
首次发布 (实际的)
2026年9月9日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.