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

NCT07809659 | Recruiting

• 1 other identifier: DISARM CSA
• Study Type: interventional
• Target: 2,130
• Locations: 4 countries
• Sites: 6

Brief 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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (16)

• Recruitment Rate

  Proportion of eligible individuals who consent to enroll in the study.

  Month 12

• Retention Rate

  Proportion of enrolled participants who complete the study through final assessment.

  Month 12

• CanRisk Data Completeness

  Proportion of CanRisk assessments completed with full data entry.

  Month 12

• Time to Complete CanRisk Assessment vs. Standard Practice

  Average time required to complete a CanRisk-based risk assessment compared with standard practice risk assessment.

  Month 12

• Consultation and Assessment Workflow Timelines

  Time required for consultation and assessment workflow processes associated with the CanRisk-based assessment.

  Month 12

• Usability of CanRisk (System Usability Scale)

  Usability of the CanRisk tool as rated by healthcare professionals using the System Usability Scale (SUS), assessed at mid-study and end of study.

  Month 6 & 12

• Qualitative Implementation Assessment (CFIR)

  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.

  Month 12

• Acceptability by Healthcare Professionals (TFA Questionnaire)

  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.

  Month 6 &12

• HCP Satisfaction with CanRisk vs. Standard Practice

  Proportion of healthcare professionals reporting satisfaction with CanRisk versus standard practice assessment, assessed at mid-study and end of study.

  Month 6 & 12

• HCP Willingness to Continue Using CanRisk

  Proportion of healthcare professionals indicating willingness to continue using CanRisk after study completion, assessed at mid-study and end of study.

  Month 6 & 12

• Qualitative Feedback from Healthcare Professionals

  Number and type of themes identified from focus groups and/or semi-structured interviews with healthcare professionals, at end of study.

  Month 12

• Acceptability by Study Participants (TFA Questionnaire)

  Acceptability of risk assessment results among study participants, measured using the TFA Generic Questionnaire, administered immediately after delivery of results.

  Immediately following delivery of risk assessment results

• Incremental Mean Cost per Participant

  Incremental mean cost per participant at 12 months, including assessment-related and downstream care costs incurred within follow-up.

  Month 12

• Incremental Cost per Completed Risk Assessment

  Incremental cost per completed CanRisk-based risk assessment.

  Month 12

• Incremental Quality-Adjusted Life Years (QALYs)

  Incremental quality-adjusted life years accrued over 12 months, comparing CanRisk-based assessment to standard practice.

  Month 12

• Descriptive Subgroup Summaries of Costs and Outcomes

  Descriptive summary of costs and outcomes across pre-specified subgroups.

  Month 12

Study Arms (2)

CanRisk Intervention

EXPERIMENTAL

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.

Other: CanRisk

Standard Care

ACTIVE COMPARATOR

Participants receive standard clinical genetic assessment and management according to national clinical practice without CanRisk-guided risk estimation

Other: Standard clinical risk assessment

Interventions

CanRisk OTHER

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.

CanRisk Intervention

Standard clinical risk assessment OTHER

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

Standard Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Portugues Oncologia de Lisboa Francisco Gentil: lead
• European Commission: collaborator

Study Sites (6)

Vseobecna Fakultni Nemocnice V Praze

Prague, 12808, Czechia

RECRUITING

Fakultni Nemocnice Bulovka

Prague, 180000, Czechia

RECRUITING

National Centre for Scientific Research Demokritos

Athens, Attica, 15341, 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, 1099-023, Portugal

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Fatima VAZ

CONTACT

+351217229800; fvaz@ipolisboa.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fátima VAZ, Senior Consultant Medical Oncology

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: September 9, 2026
• Study Start: August 6, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

GR (2); CZ (2); PT (1); LI (1)