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The cost-effectiveness of preselection for non-invasive pre-assessment of women referred to full hospital assessment on the basis of a positive screening examination for breast cancer

The cost-effectiveness of preselection for non-invasive pre-assessment of women referred to full hospital assessment on the basis of a positive screening examination for breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20654
Enrollment
4568
Registered
2008-10-06
Start date
2009-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cost-effectiveness breast cancer screening pre-assessment referral rate

Interventions

The modified assessment strategy -i.e. the intervention- can be summarised as follows. All women referred for further assessment will be classified in three groups, using the BI-RADS classification
- Women with a BI-RADS code 4 or 5 (suspicious for malignancy) will be referred to full hospital assessment, as in current screening practice, since non-invasive pre-assessment will not be sufficient
- Women with a BI-RADS code 0 (more information needed) will be referred (within 2 working days) for non-invasive pre-assessment in the screening setting consisting of additional or magnification mamm

Sponsors

Radboud University Nijmegen Medical Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Included are all women who are screened at the participating units and are referred on the basis of a positive screening examination.

Exclusion criteria

Exclusion criteria: 1. Those who are not able to understand the Dutch language (informed consent) 2. Those who are in a state of diminished responsibility 3. Those who are mentally disabled.

Design outcomes

Primary

MeasureTime frame
- Negative predictive value

Secondary

MeasureTime frame
- Quality of life - Anxiety - Satisfaction with the assessment strategy

Contacts

Public ContactM.J.M. Broeders

Radboud University Nijmegen Medical Centre Department of Epidemiology, Biostatistics and HTA PO Box 9101

M.Broeders@ebh.umcn.nl+31 (0)24 3619132

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)