PRISMA study: Personalised RISk-based MAmmascreening

Recruiting

• Conditions: breast cancer; mamma carcinoma; 10006291

• Registration Number: NL-OMON44455
• Lead Sponsor: Health Evidence

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 90000

Inclusion Criteria

- Women invited for breast cancer screening
- Able to communicate in Dutch
- Able to read and understand the participant information and informed consent form

Exclusion Criteria

- Women who cannot make the decision to participate by themselves (mentally ill or mentally handicapped)
- Not able to fill out a web-based questionnaire

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Since the purpose of this study is developing a risk prediction model for<br /><br>breast cancer, there is no primary study parameter as such. Measures to compare<br /><br>the current risk prediction models and the newly developed models will be the<br /><br>Area under the Receiver Operator Characteristic curve (AUCROC), decision<br /><br>analytic measures, like the Net Reclassification Improvement (NRI), and the<br /><br>Integrated Discrimination Improvement (IDI).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We will use the well-establised MISCAN model to assess the cost-effectiveness<br /><br>of the most promising risk-based screening scenarios.</p><br>