CanRisk-Based Ovarian Cancer Risk Assessment Versus Standard Practice (DISARM CSA) (DISARM CSA)
2026년 9월 2일 업데이트: 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
2130
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Athens, 그리스
- 모병
- Dept of Clinical Therapeutics, Alexandra Hospital
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연락하다:
- Michael Liontos
- 전화번호: +302132162845
- 이메일: mlionto@med.uoa.gr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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활성 비교기: Standard Care
Participants receive standard clinical genetic assessment and management according to national clinical practice without CanRisk-guided risk estimation
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Standard clinical genetic counselling, genetic testing and risk assessment according to national clinical practice, without use of the CanRisk tool.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment Rate
기간: Month 12
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Proportion of eligible individuals who consent to enroll in the study.
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Month 12
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Retention Rate
기간: Month 12
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Proportion of enrolled participants who complete the study through final assessment.
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Month 12
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CanRisk Data Completeness
기간: Month 12
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Proportion of CanRisk assessments completed with full data entry.
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Month 12
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Time to Complete CanRisk Assessment vs. Standard Practice
기간: Month 12
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Average time required to complete a CanRisk-based risk assessment compared with standard practice risk assessment.
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Month 12
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Consultation and Assessment Workflow Timelines
기간: Month 12
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Time required for consultation and assessment workflow processes associated with the CanRisk-based assessment.
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Month 12
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Usability of CanRisk (System Usability Scale)
기간: Month 6 & 12
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Usability of the CanRisk tool as rated by healthcare professionals using the System Usability Scale (SUS), assessed at mid-study and end of study.
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Month 6 & 12
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Qualitative Implementation Assessment (CFIR)
기간: Month 12
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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.
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Month 12
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Acceptability by Healthcare Professionals (TFA Questionnaire)
기간: Month 6 &12
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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.
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Month 6 &12
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HCP Satisfaction with CanRisk vs. Standard Practice
기간: Month 6 & 12
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Proportion of healthcare professionals reporting satisfaction with CanRisk versus standard practice assessment, assessed at mid-study and end of study.
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Month 6 & 12
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HCP Willingness to Continue Using CanRisk
기간: Month 6 & 12
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Proportion of healthcare professionals indicating willingness to continue using CanRisk after study completion, assessed at mid-study and end of study.
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Month 6 & 12
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Qualitative Feedback from Healthcare Professionals
기간: Month 12
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Number and type of themes identified from focus groups and/or semi-structured interviews with healthcare professionals, at end of study.
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Month 12
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Acceptability by Study Participants (TFA Questionnaire)
기간: Immediately following delivery of risk assessment results
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Acceptability of risk assessment results among study participants, measured using the TFA Generic Questionnaire, administered immediately after delivery of results.
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Immediately following delivery of risk assessment results
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Incremental Mean Cost per Participant
기간: Month 12
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Incremental mean cost per participant at 12 months, including assessment-related and downstream care costs incurred within follow-up.
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Month 12
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Incremental Cost per Completed Risk Assessment
기간: Month 12
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Incremental cost per completed CanRisk-based risk assessment.
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Month 12
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Incremental Quality-Adjusted Life Years (QALYs)
기간: Month 12
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Incremental quality-adjusted life years accrued over 12 months, comparing CanRisk-based assessment to standard practice.
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Month 12
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Descriptive Subgroup Summaries of Costs and Outcomes
기간: Month 12
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Descriptive summary of costs and outcomes across pre-specified subgroups.
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Month 12
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
스폰서
협력자
협력자
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 8월 6일
기본 완료 (추정된)
기본 완료
2028년 9월 1일
연구 완료 (추정된)
연구 완료
2028년 9월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 22일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 9월 2일
처음 게시됨 (실제)
처음 게시됨
2026년 9월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 9일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 2일
마지막으로 확인됨
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- DISARM CSA
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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