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.
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
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
Parallel
CanRisk
Other interventionRisk 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.
Standard clinical risk assessment
Other interventionStandard clinical genetic counselling, genetic testing and risk assessment according to national clinical practice, without use of the CanRisk tool.
Recruitment Rate
Proportion of eligible individuals who consent to enroll in the study.
Retention Rate
Proportion of enrolled participants who complete the study through final assessment.
CanRisk Data Completeness
Proportion of CanRisk assessments completed with full data entry.
Time to Complete CanRisk Assessment vs. Standard Practice
Average time required to complete a CanRisk-based risk assessment compared with standard practice risk assessment.
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Instituto Portugues Oncologia de Lisboa Francisco Gentil
Lead sponsor
European Commission
Collaborator
