|- candidate number||21951|
|- NTR Number||NTR5175|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-apr-2015|
|- Secondary IDs||K15-17 METC Twente|
|- Public Title||Detection of lung cancer from exhaled air with e-Nose|
|- Scientific Title||Detection of lung cancer from exhaled air with e-Nose|
|- hypothesis||Can the eNose detect VOC patterns that distinguish between patients with and without lung cancer?|
|- Healt Condition(s) or Problem(s) studied||Lung cancer|
|- Inclusion criteria||Subjects suspected for lung cancer:|
1. Scheduled to undergo CT-scanning;
2. They have suspicion of lung cancer based on the one or more of the following points:
a. Respiratory symptoms such as: haemoptysis, coughing, dyspnoea;
b. General symptoms that go with malignancy, such as: weight loss, nocturnal hyperhidrosis, fever, and/or loss of appetite;
c. An anomalous chest X-ray;
3. Age ≥ 40 years;
4. Smoker or ex-smoker.
1. A negative history of chest symptoms, for example asthma, COPD, other respiratory conditions.
|- Exclusion criteria||Subjects suspected for lung cancer:|
1. Subjects with other prior known malignancies;
2. Subjects with a history of upper or lower respiratory tract infection during the past 4 weeks prior to measurements which required pharmacological treatment with antibiotics or systemic corticosteroids.
1. Subjects with known significant metabolic disease, such as: diabetes mellitus, liver failure or active liver disease, renal failure, haemodialysis or cardiac failure, because of possible (un)known effects on metabolism;
2. Subjects with known COPD;
3. Subjects with an underlying malignancy.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-mei-2015|
|- planned closingdate||1-mei-2016|
|- Target number of participants||300|
|- Interventions||Measurement of exhaled breath with an electronic nose.|
|- Primary outcome||Detection of differences in patterns of exhaled breath in patients diagnosed with lung cancer from subjects with a rejected diagnosis of lung cancer and healthy subjects.|
|- Secondary outcome||- Detection of different patterns of exhaled breath in different lung cancer stages.|
- Detection of different patterns of exhaled breath in different types of lung cancer.
|- Timepoints||Lung cancer: yes or no. 1 measurement|
Type of lung cancer: NSCLC or SCLC. 1 measurement
Stadium of lung cancer: TNM classification and staging. 1 measurement.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Sharina Kort|
|- CONTACT for SCIENTIFIC QUERIES|| Sharina Kort|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|The eNose Company|
|- Brief summary||There is not yet a quick test, nor a non-invasive method to identify subjects with lung cancer. The Aeonoseô (electronic nose) is a diagnostic test device to detect patterns of volatile organic compounds (VOCís) in exhaled air. These VOCís are related to metabolic activities in the body. It is assumed that the disease-specific metabolic pathways may give rise to specific VOC patterns and therefore aid in the diagnostic process. Pilot studies have already indicated that electronic noses, consisting of an array of VOC-sensors, may be used to detect diseases in different diagnostic areas, including malignancies.
The aim of this study is to investigate whether the eNose can detect VOC patterns that distinguish between patients suspected for lung cancer with a confirmed histopathological diagnosis and patients suspected for lung cancer with a rejected diagnosis of lung cancer. Also, we want to compare VOC patterns of those with a confirmed diagnosis of lung cancer with healthy subjects without any suspicion for lung cancer.
|- Main changes (audit trail)|
|- RECORD||15-apr-2015 - 5-jul-2015|