1. To determine the diagnostic accuracy of the electronic nose in the identification of lung cancer in new (referred for suspicion of lung cancer) patients based on the algorithm developed in the SCENT study part 1 (training-set).2. To determine theā¦
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity, specificity, positive and negative predictive value of the eNose
combined with the statistical algorithm developed from the training-set in the
SCENT study part 1.
Secondary outcome
not applicable
Background summary
Lung and breast cancer are leading causes of cancer-related death. Early
detection of lung cancer is considered crucial to decrease mortality, and in
particular non-invasive diagnostic strategies aimed at identifying biomarkers
of lung cancer are of great interest. Lung cancer is clinically divided into
two sub-types, small cell lung cancer, (SCLC; 10-15% of lung cancer cases), and
non-small cell lung cancer (NSCLC (subdivided into mainly adenocarcinoma and
squamous cell carcinoma); 85-90% of cases). It has been shown that distinct
biochemical markers have been found in the exhaled breath of patients with lung
and breast cancer that could be discriminated from those of controls,
suggesting that VOC analysis might be used as a non invasive marker of these
cancers. The electronic noses based on pattern recognition without analyzing
the individual molecular components might be sufficient for diagnostic
objectives. In the present study we will use the results obtained in the SCENT
study part 1 (*differences in smellprints between patients with non small cell
lung cancer and breast cancer*). In that study the electronic nose will be
trained to develop the algorithm to discriminate patients with confirmed
diagnoses of non small cell lung cancer or breast cancer from controls. On the
condition that such a discriminating algorithm can be deduced from the results
of part 1, in this study (part 2 of the SCENT study) we will test the
hypothesis that smellprints can identify and classify newly presented patients
prospectively into the categories of non small cell lung cancer (NSCLC) and
breast cancer
Study objective
1. To determine the diagnostic accuracy of the electronic nose in the
identification of lung cancer in new (referred for suspicion of lung cancer)
patients based on the algorithm developed in the SCENT study part 1
(training-set).
2. To determine the diagnostic accuracy of the electronic nose in the
identification of breast cancer in new (referred for suspicion of breast
cancer) patients based on the algorithm developed in the SCENT study part 1
(training-set).
Study design
diagnostical study.
Study burden and risks
All persons, patients and controls, will visit the pulmonary function
department once. They first will complete a questionnaire obtaining information
about medical history, smoking history en actual medical condition. Then
exhaled breath collection will take place after 5 min tidal breathing VOC
filtered room air. Finally spirometry will be performed. Total time will not
exceed 20 min.
Both groups (breast cancer and lung cancer) are chosen, because they are
leading causes of death and both have much better perspectives when diagnosed
at early stage. eNose technology might be of great value in the screening and
monitoring of these two cancers.
H Dunantweg 34
8934 AD Leeuwarden
NL
H Dunantweg 34
8934 AD Leeuwarden
NL
Listed location countries
Age
Inclusion criteria
1. all women (18-80 yr) suspected of having breast cancer, referred to the OPD specialised in the diagnostic work-up of breast abnormalities in our hospital (*mamma poli*) will be asked to participate (intention-to-diagnose).
2. all patients (18-80 yr) suspected of having lung cancer, referred to the pulmonary OPD in our hospital will be asked to participate (intention-to-diagnose).
Exclusion criteria
Patients of whom it is not possible to make the diagnose lung cancer or breast cancer.
eating (including chewing gum), drinking,brushing teeth, smoking < 3 hours before measurements.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL25946.099.08 |
Other | volgt: aanvraagnr 4829: trialregister.nl |