Colorectal Cancer Clinical Trial
Official title:
Volatile Organic Compounds in Breath and Headspace Analysis - Diagnostic and Monitoring Markers for Diseases
Detection of Volatile Organic Compounds (VOC) directly from tissue by headspace analysis (skin, surgery material, other tissue) and exhaled breath is feasible using affordable user-friendly novel nano-chemo sensors that can accurately be used for screening and monitoring purpose
Study propose to explore a novel approach for the diagnosis and monitoring of diseases. The
approach is based on the detection of volatile organic compounds (VOCs) that are emitted from
the cells and detected directly from tissue, such as skin, surgery material, blood as well as
from exhaled breath.
In the literature there are several reports on VOCs which can be detected by Gas
Chromatography - Mass Spectrometry (GC-MS) means directly from: (i) the headspace of TB cells
(i.e., the mixture of volatile biomarkers trapped above the TB cells in a sealed vessel);
(ii) the exhaled breath or (iii) from urine. Excellent results in detection of the
tuberculosis disease by using nanosensor array were shown by Nakhleh et al achieved 90%
sensitivity, 93% specificity and 92% accuracy in discrimination between healthy and diseased
patients using electronic nose devices with a single sensor. None of the reported studies
identified the tentative recognition of the tuberculosis-related VOCs and quantified the
concentration differences between samples from ill and healthy controls. Further
investigation of the exhaled breath tuberculosis-related VOC by GC-MS means will improve the
knowledge and simultaneously will help to improve the nanosensor array design.
Several studies have shown that disease-rated VOC patterns can be transmitted through the
skin, and, therefore, skin can be used as a source for disease detection and identification.
The principle of this detection approach is that disease-related changes are reflected in
measurable changes in the skin through exchange via the blood. In addition, several studies
have suggested that the VOC levels are elevated even in early stages of the disease, because
they reflect a change in the human's body chemistry (as a result of the development of
disease condition), rather than the amount of infected cells. Complementary studies have
shown that VOCs can be emitted to the skin within minutes after they have emerged in the
infected part of the human's body. What is particularly significant about this approach is
that each type of (infectious) disease has its own unique pattern of VOCs, and, therefore,
the presence of one (infectious) disease would not screen other disease types. Nevertheless,
to the best of our knowledge, the detection of tuberculosis VOCs through skin has not been
examined yet. Additionally, all studies targeting skin VOCs have been carried out by means of
spectrometry and spectroscopy techniques. In few cases, electronic nose devices were used.
These techniques are powerful tools for detecting VOCs. However, to date, the use of these
techniques has been impeded by the need for moderately to highly expensive equipment's, the
high levels of expertise required to operate such instruments, the speed required for
sampling and analysis, and the need for preconcentration techniques. For VOC skin testing and
breath testing of tuberculosis to become widely used in clinical practice, several advances
in the knowledge of tuberculosis specific VOCs and sensor development need to occur.
Nanoparticles containing flexible sensors, based on organic films, are more likely to become
a clinical diagnostic tool, because they are significantly smaller, easier-to-use, and
significantly less expensive.
In recent years comprehensive studies have shown excellent data for using VOCs from exhaled
breath as tool for diagnosing gastric cancer. In one of the biggest studies carried out by
Chinese and Latvian centers, malignancy could be identified with 89% sensitivity and 90%
specificity after cross-validation, irrespective of important confounding factors in gastric
patients such as tobacco or alcohol consumption and H. pylori infection. A breath test for GC
staging could also be demonstrated by distinguishing stage I&II cancers from stage III&IV
cancers with 89% sensitivity and 94% specificity. These studies used both - mass spectometry
and nano-sensors technologies. Most recent study published in ASC Nano journal in January
2017 reported on more extended use of nanoarry sensors in breath analysis, blind experiments
showed that 86% accuracy could be achieved with the artificially intelligent nanoarray,
allowing both detection and discrimination between the different disease conditions examined
(chronic kidney failure, idiopathic Parkinson's disease, atypical Parkinsonism , multiple
sclerosis, Crohn's disease, ulcerative colitis, irritable bowel syndrome, pulmonary arterial
hypertension, pre-eclampsia in pregnant women, head and neck cancer, lung cancer, colorectal
cancer, bladder cancer, kidney cancer, prostate cancer, gastric cancer, and ovarian cancer.
Analysis of the artificially intelligent nanoarray also showed that each disease has its own
unique breathprint, and that the presence of one disease would not screen out others.
Therefore, this study is aimed to test VOCs detecting technologies as diagnostic and
monitoring tools for digestive tract and infectious diseases.
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