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Borstkanker vaststellen met een ademtest met een electronische neus

Diagnosing Mamma Carcinoma using an electronic nose; A Validation study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28999
Enrollment
800
Registered
2017-07-14
Start date
2016-10-01
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

breath analysis

Interventions

Aeonose-based signatures of exhaled breath will be obtained from patients with suspected BC and a control group, paralleled by phenotyping of the BC patients according to the gold standard.

Sponsors

Alexander Monro Hospital, Bilthoven Medisch Spectrum Twente, Enschede Ziekenhuis Bernhoven, Uden
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Patients entering the hospital with suspected BC • Patients age of 18 years and older • Signed informed consent

Exclusion criteria

Exclusion criteria: Patients with a history of proven primary BC and other malignancies, • Patients currently treated with radio- or chemotherapy.

Design outcomes

Primary

MeasureTime frame
Primary parameters of diagnostic relevance will be sensitivity, specificity, positive and negative likelihood ratio, and positive and negative predicted value of the Aeonose. Histopathological examination of the biopsies is considered the gold standard.

Secondary

MeasureTime frame
Patients Reported Outcome measures Cost-effectiveness analysis (Markov model)

Contacts

Public ContactAnja Timmer-Bonte
anjatimmer-bonte@alexandermonro.nl030-7210100

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)