- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07809659
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Athens, Grecia
- Reclutamiento
- Dept of Clinical Therapeutics, Alexandra Hospital
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Contacto:
- Michael Liontos
- Número de teléfono: +302132162845
- Correo electrónico: mlionto@med.uoa.gr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recruitment Rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema endocrino
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades Genitales Femeninas
- Neoplasias de glándulas endocrinas
- Enfermedades Ováricas
- Enfermedades anexiales
- Neoplasias Genitales Femeninas
- Trastornos gonadales
- Neoplasias Ováricas
Otros números de identificación del estudio
- DISARM CSA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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