|- candidate number||8382|
|- NTR Number||NTR2485|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-aug-2010|
|- Secondary IDs||NL31826.018.10 MEC AMC|
|- Public Title||eNose analysis of air sampled by bronchoscopy.|
|- Scientific Title||eNose analysis of air sampled by bronchoscopy.|
|- ACRONYM||BronchoNose study|
|- hypothesis||A diagnostic algorithm based on tumour-site specific volatile organic compounds (VOCs) enables improved discrimination of lung cancer patients and controles , compared to exhaled breath sampling.|
|- Healt Condition(s) or Problem(s) studied||Lung cancer, Electric nose, Bronchoscopy|
|- Inclusion criteria||1. Subjects with clinical suspicion of lung cancer, based on a unilateral pulmonary lesion on chest X-ray and/or computed tomography of the thorax, in whom diagnostic bronchoscopy will be performed;|
2. Healthy volunteers undergoing bronchoscopy for scientific purposes.
|- Exclusion criteria||1. General contraindications for bronchoscopy;|
2. Age < 18 years.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||9-apr-2010|
|- planned closingdate||31-dec-2010|
|- Target number of participants||70|
|- Interventions||1. Exhaled breath sampling;|
|- Primary outcome||1. The endobronchial VOC-profiles of tumour side and contralateral side in lung cancer patients;|
2. Endobronchial VOC profiles in healthy subjects;
3. Exhaled breath VOC profiles in both patients and healthy subjects.
|- Secondary outcome||N/A|
|- Timepoints||One visit. All measurements take place at the same day (exhaled breath and endobronchial air sampling followed by electronic nose analysis).|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| G.J. Ilbrink|
|- CONTACT for SCIENTIFIC QUERIES||MD L.N. Venekamp|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam|
|- Brief summary||Background of the study:|
Various study’s based on analysis of exhaled Volatile Organic Compounds (VOCs) have shown the diagnostic potential of exhaled breath analysis or ‘Breatheomics’ in detecting novel biomarkers of disease. eNose technology is based upon pattern-recognition of volatile organic compounds. This methodology does not allow to analyze specific VOCs but integratively to assess all VOCs and there relative interactions with the sensor array.
As of now it is unknown whether the lung cancer specific VOCs represent a more general effect on homeostasis of a developing neoplasm or originate from the site of the tumor itself as most of the identified components have been related to increased oxidative stress. A previous study by our group however showed that COPD and NSCLC have a different VOC-profile suggesting that tumor specific volatile organic compounds are present. VOCs originating from the tumor itself are most likely more specific for the tumor than the VOCs that originate from the increased oxidative stress on the body. Detection of tumor-site specific volatile organic compounds can increase our knowledge of pathophysiological changes that occur in developing lung cancer.
Objective of the study:
We hypothesize that a diagnostic algorithm based on tumor site-specific VOCs enables improved discrimination of lung cancer patients and controls compared to exhaled breath sampling.
This will be a cross-sectional comparative study including 2 groups of subjects with one study visit. During the study visit, subjects will perform eNose assessment of exhaled breath, followed by bronchoscopy including bronchoscopic eNose sampling.
The study will include 2 groups of subjects:
Group 1: 40 Patients with a clinical suspicion of lung cancer, based on a pulmonary lesion on chest-X-ray and/or computed tomography (CT) of the thorax, in whom diagnostic bronchoscopy will be performed.
Group 2: 30 Subjects undergoing bronchoscopy for scientific reasons.
Primary study parameters/outcome of the study:
Tumour-specific VOC-pattern of endobronchial sampled air and exhaled breath.
|- Main changes (audit trail)|
|- RECORD||30-aug-2010 - 9-sep-2010|