- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Athens, Grekland
- Rekrytering
- Dept of Clinical Therapeutics, Alexandra Hospital
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Kontakt:
- Michael Liontos
- Telefonnummer: +302132162845
- E-post: mlionto@med.uoa.gr
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recruitment Rate
Tidsram: Month 12
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Proportion of eligible individuals who consent to enroll in the study.
|
Month 12
|
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Retention Rate
Tidsram: Month 12
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Proportion of enrolled participants who complete the study through final assessment.
|
Month 12
|
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CanRisk Data Completeness
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Month 12
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Acceptability by Study Participants (TFA Questionnaire)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Sjukdomar i det endokrina systemet
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Genitala sjukdomar, kvinnor
- Neoplasmer i endokrina körtel
- Ovariella sjukdomar
- Adnexala sjukdomar
- Genitala neoplasmer, hona
- Gonadal sjukdomar
- Ovariella neoplasmer
Andra studie-ID-nummer
- DISARM CSA
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