|- candidate number||27553|
|- NTR Number||NTR6640|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-jul-2017|
|- Secondary IDs||K16-74 METC Twente|
|- Public Title||Borstkanker vaststellen met een ademtest met een electronische neus|
|- Scientific Title||Diagnosing Mamma Carcinoma using an electronic nose; A Validation study
|- hypothesis||To validate the diagnostic performance of the electronic nose, the AeonoseTM, by analysing Volatile Organic Compounds (VOC) patterns in exhaled breath from patients with Mamma Carcinoma (BC) versus controls.|
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Breath analysis, Electronic nose|
|- Inclusion criteria||• Patients entering the hospital with suspected BC |
• Patients age of 18 years and older
• Signed informed consent
|- Exclusion criteria||Patients with a history of proven primary BC and other malignancies, |
• Patients currently treated with radio- or chemotherapy.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-okt-2016|
|- planned closingdate||1-okt-2018|
|- Target number of participants||800|
|- 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. |
|- Primary outcome||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 outcome||Patients Reported Outcome measures |
Cost-effectiveness analysis (Markov model)
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Anja Timmer-Bonte|
|- CONTACT for SCIENTIFIC QUERIES|| Anja Timmer-Bonte|
|- Sponsor/Initiator ||Medisch Spectrum Twente, Alexander Monro Hospital, Bilthoven, Ziekenhuis Bernhoven, Uden|
(Source(s) of Monetary or Material Support)
|Alexander Monro foundation, AeonoseTM provided by Enose Company|
|- Publications||9. Timmer-Bonte J, Grosfeld, N. Seelen-Janssen, L. Veenendaal, F. Zijlstra. Breast cancer diagnosis and subtyping by analysing exhaled breath: A pilot study using a portable electronic nose (Aeonose®). European Journal of Cancer supl.2 (2016) #496|
|- Brief summary||The diagnosis of breast cancer is based on clinical examination in combination with imaging, and confirmed by pathological assessment. In the majority (16,9/23,5) BC is not confirmed; in approximately one third (5,6 of 16,9 non-BC affected) invasive diagnostic procedures (biopsy) need to be performed. |
Women with false-positive results reported more anxiety, distress, and breast cancer-specific worry, although results varied across 80 observational studies. Thirty-nine observational studies indicated that some women reported pain during mammography (1% to 77%); of these, 11% to 46% declined future screening.
More convenient and accurate BC screening and diagnosis should be pursued, therefore.
In the past decades, Volatile Organic Compounds (VOC’s) were broadly used as diagnostic biomarkers in medicine. Using sniffer dogs, gas chromatography, mass spectroscopy or pattern recognition, VOC’s can be detected in exhaled breath, faeces or urine. The list of diagnostic applications of VOC’s, such as inflammatory lung diseases and cancer, rapidly expands. In a pilot study of Leunis et al. breath samples of 36 currently smoking patients with histopathological proven HNSCC and 23 cancer-free currently smoking controls were analysed using VOC pattern recognition with an electronic nose (Aeonose). Metal oxide sensors within the Aeonose are periodically heated when processing the breath sample. Oxidation or reduction of VOCs present in the breath sample is measured as resistance changes as a function of temperature and time.
Early results with the Aeonose to diagnose BC showed promising results with high sensitivities and specificities especially for the detection of the relatively homogeneous ILC.
|- Main changes (audit trail)|
|- RECORD||14-jul-2017 - 27-aug-2017|