Taking people in PortugalNo phase

Comparing a personalised risk tool with usual care for ovarian cancer risk

Compares two ways to estimate ovarian cancer risk in cancer-free people.

Key facts

Who runs it: Instituto Portugues Oncologia de Lisboa Francisco Gentil
Where: Lisbon, PortugalSee the siteAlso in 3 other countries, 5 sites
Trial code: NCT07809659
Registry title: CanRisk-Based Ovarian Cancer Risk Assessment Versus Standard Practice (DISARM CSA)
Status: Recruiting
People taking part: 2,130 people, planned
Started: 6 Aug 2026
Expected to end: Sept 2028
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: CanRisk
Standard clinical risk assessment
Record updated: 29 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for cancer-free adults with a family history of ovarian, fallopian tube or peritoneum cancer, or with a family member who carries a gene change linked to ovarian cancer risk. It compares two ways of assessing ovarian cancer risk.

Age: 18 to 75 years
Sex: Women, trans men and non-binary people with female reproductive organs
Disease stage: No cancer diagnosis. The trial is for people who may have an increased risk of ovarian cancer.
Earlier treatment: People who have had surgery to remove the tubes and ovaries to lower cancer risk (RRSO) cannot join. People who already had a multifactorial risk assessment cannot join.
Biomarker or test result: Either a family history suggesting higher risk of ovarian, fallopian tube or peritoneum cancer, or a family member found to have a pathogenic variant (PV) linked to ovarian cancer risk.

Main reasons for not taking part

Has had any cancer
Has had risk-reducing surgery to remove tubes and ovaries (RRSO)
Has already had a multifactorial risk assessment, using CanRisk or another tool
Cannot give informed consent
Not expected to stay in the study area during follow-up

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

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

Who cannot take part

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)
Personal history of cancer
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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 75 years old?

Where in Portugal

Also in 3 other countries, 5 sites

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.Lisbon, PortugalContact: Fatima VAZTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

CanRisk InterventionTreatment being tested
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.
Treatment: CanRisk
Standard CareExisting treatment, for comparison
Participants receive standard clinical genetic assessment and management according to national clinical practice without CanRisk-guided risk estimation
Treatment: Standard clinical risk assessment