Performance of the Aeonose™ as a diagnostic tool to detect lung cancer: an external validation study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20226

Enrollment

800

Registered

2018-05-24

Start date

2018-05-22

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

None listed

Interventions

Measurement of exhaled breath with an electronic nose.

Eligibility

Inclusion criteria

Inclusion criteria: To be eligible as a patient to participate in this study, subjects need to match the following inclusion criteria: • Referred for a CT scan and/or a histological biopsy due to suspicion for lung cancer. • Age above 18 years. Eligible healthy subjects need to meet the following criterion: • Age above 50 years.

Exclusion criteria

Exclusion criteria: Potential subjects will be excluded from participation in this study when meeting the following criterion: • Known to have an active malignancy.

Design outcomes

Primary

Measure	Time frame
the comparison of outcomes obtained from the Aeonose™ (21) with the outcomes obtained from the gold standard, which is histopathology. The outcomes will be presented as sensitivity, specificity, positive predictive value, negative predictive value and the AUC for the Aeonose™ as a diagnostic test to predict the probability of lung cancer.	—

Secondary

Measure	Time frame
Secondary study parameters are smoking status including amount of pack years, comorbidities, medication use, age and sex to describe the study population. In case of presence of lung cancer, clinical parameters such as tumour type and TNM stadium are noted.	—

Contacts

Public ContactSharina Kort

Deurningerstraat 54

s.kort@mst.nl0031651421840

Outcome results