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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
2130
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Athens、ギリシャ
- 募集
- Dept of Clinical Therapeutics, Alexandra Hospital
-
コンタクト：
- Michael Liontos
- 電話番号：+302132162845
- メール：mlionto@med.uoa.gr
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment Rate
時間枠：Month 12
|
Proportion of eligible individuals who consent to enroll in the study.
|
Month 12
|
|
Retention Rate
時間枠：Month 12
|
Proportion of enrolled participants who complete the study through final assessment.
|
Month 12
|
|
CanRisk Data Completeness
時間枠：Month 12
|
Proportion of CanRisk assessments completed with full data entry.
|
Month 12
|
|
Time to Complete CanRisk Assessment vs. Standard Practice
時間枠：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
時間枠：Month 12
|
Time required for consultation and assessment workflow processes associated with the CanRisk-based assessment.
|
Month 12
|
|
Usability of CanRisk (System Usability Scale)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：Month 12
|
Incremental cost per completed CanRisk-based risk assessment.
|
Month 12
|
|
Incremental Quality-Adjusted Life Years (QALYs)
時間枠：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
時間枠：Month 12
|
Descriptive summary of costs and outcomes across pre-specified subgroups.
|
Month 12
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年8月6日
一次修了 (推定)
2028年9月1日
研究の完了 (推定)
2028年9月1日
試験登録日
最初に提出
2026年7月22日
QC基準を満たした最初の提出物
2026年9月2日
最初の投稿 (実際)
2026年9月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月9日
QC基準を満たした最後の更新が送信されました
2026年9月2日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。