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RECRUITING
NCT07809659
NA

CanRisk-Based Ovarian Cancer Risk Assessment Versus Standard Practice (DISARM CSA)

Sponsor: Instituto Portugues Oncologia de Lisboa Francisco Gentil

View on ClinicalTrials.gov

Summary

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.

Official title: Operationalising Multifactorial Ovarian Cancer Risk Assessment Using the CanRisk Tool Versus Standard Practices.

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

2130

Start Date

2026-08-06

Completion Date

2028-09

Last Updated

2026-09-09

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

CanRisk

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.

OTHER

Standard clinical risk assessment

Standard clinical genetic counselling, genetic testing and risk assessment according to national clinical practice, without use of the CanRisk tool.

Locations (1)

Dept of Clinical Therapeutics, Alexandra Hospital

Athens, Greece