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NCT07809659From ClinicalTrials.govRecruiting

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

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

  • Ovarian Cancer

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Instituto Portugues Oncologia de Lisboa Francisco Gentil
Enrolment target
2,130
Started
6 August 2026
Main results due
September 2028
Study sites
6
Registry updated
29 September 2026

Can you take part?

  • Ages 18 years to 75 years.
  • Women only.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

1. Women, trans men, non-binary people with female reproductive organs
2. Aged 18 to 75 years
3. 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
4. Able to give informed consent
5. Expected to remain in the study catchment area for the duration of follow-up.

Exclusion Criteria:

1. Personal history of cancer
2. Previously undergone Risk-Reducing Salpingo-Oophorectomy (RRSO)
3. Previously undergone multifactorial risk assessment (using CanRisk or another tool) incorporating risk factors, family history and genetic testing (panel +/- PGS)
4. 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(6)

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, Czechia

    Recruiting

  • Fakultni Nemocnice Bulovka

    Prague, Czechia

    Recruiting

  • National Centre for Scientific Research Demokritos

    Athens, Attica, Greece

    Recruiting

  • Dept of Clinical Therapeutics, Alexandra Hospital

    Athens, Greece

    Recruiting

  • Lithuanian University of Health Sciences

    Kaunas, Lithuania

    Not yet recruiting

  • Instituto Português de Oncologia de Lisboa Francisco Gentil E.P.E.

    Lisbon, Portugal

    Recruiting

Showing 6 of 6 sites. 5 of the 6 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07809659. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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