An observational study in Tuberculosis, Gastric Cancer and Peptic Ulcer, sponsored by University of Latvia. Enrolling by invitation at 1 site in Latvia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-21.
Sponsored by University of Latvia · Observational
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 253 across 317 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →University of Latvia is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
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Patients being referred for diagnostic testing and treatment Healthy individuals from general population
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with Active Tuberculosis Disease Intervention: Diagnostic Test: VOC detection in breath and in skin headspace Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Breath sampling Intervention: Headspace analysis for biological material
Diagnostic Test: VOC detection in breath and in skin headspace · Diagnostic Test: Breath sampling · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Headspace analysis for biological material
Participants Without Active Tuberculosis Disease Intervention: Diagnostic Test: VOC detection in breath and in skin headspace Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Breath sampling Intervention: Headspace analysis for biological material
Diagnostic Test: VOC detection in breath and in skin headspace · Diagnostic Test: Breath sampling · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Headspace analysis for biological material
Patients with histologically confirmed gastric cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Feacal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical speciment
Diagnostic Test: Breath sampling · Procedure: Upper endoscopy with biopsies · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Faecal sampling · Procedure: Histological examination of surgical specimen · Diagnostic Test: Headspace analysis for biological material
Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen
Diagnostic Test: Breath sampling · Procedure: Upper endoscopy with biopsies · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Faecal sampling · Procedure: Histological examination of surgical specimen · Diagnostic Test: Headspace analysis for biological material
Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, Stage III-IV according to OLGA (Operative Link for Gastric Atrophy Assessment), and those with incomplete type of intestinal metaplasia, but excluding those with dysplasia Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Intervention: Headspace analysis for biological material
Diagnostic Test: Breath sampling · Procedure: Upper endoscopy with biopsies · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Faecal sampling · Procedure: Histological examination of surgical specimen · Diagnostic Test: Headspace analysis for biological material
Staged 0-III according to OLGIM. Dysplasia should be excluded Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material
Diagnostic Test: Breath sampling · Procedure: Upper endoscopy with biopsies · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Faecal sampling · Diagnostic Test: Headspace analysis for biological material
Patients with histologically confirmed colorectal cancer (adenocarcinoma) Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen
Diagnostic Test: Breath sampling · Procedure: Colonoscopy with biopsies · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Faecal sampling · Procedure: Histological examination of surgical specimen · Diagnostic Test: Headspace analysis for biological material
Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen
Diagnostic Test: Breath sampling · Procedure: Colonoscopy with biopsies · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Faecal sampling · Procedure: Histological examination of surgical specimen · Diagnostic Test: Headspace analysis for biological material
Patients without colorectal adenocarcinoma and without colorectal high-risk lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material
Diagnostic Test: Breath sampling · Procedure: Colonoscopy with biopsies · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Faecal sampling · Procedure: Histological examination of surgical specimen · Diagnostic Test: Headspace analysis for biological material
Patients having undergone colonoscopy without an evidence for colorectal lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen
Diagnostic Test: Breath sampling · Procedure: Colonoscopy with biopsies · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Faecal sampling · Diagnostic Test: Headspace analysis for biological material
Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material
Diagnostic Test: Breath sampling · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Faecal sampling · Diagnostic Test: Headspace analysis for biological material
Patients with histologically confirmed pancreatic cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material
Diagnostic Test: Breath sampling · Procedure: Whole blood/ Plasma / serum sampling · Procedure: Histological examination of surgical specimen · Diagnostic Test: Headspace analysis for biological material
Patients with clinically and/or histologically and/or radiologically confirmed chronic pancreatitis Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material
Diagnostic Test: Breath sampling · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Headspace analysis for biological material
Patients with histologically confirmed primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material
Diagnostic Test: Breath sampling · Procedure: Whole blood/ Plasma / serum sampling · Procedure: Histological examination of surgical specimen · Diagnostic Test: Headspace analysis for biological material
Patients with histologically confirmed liver cirrhosis of viral or other ethiology Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material
Diagnostic Test: Breath sampling · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Headspace analysis for biological material
Patients with serologically confirmed infectious disease or individuals of high risk (e.g. population in season of flu epidemy). This group does not include tuberculosis Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material
Diagnostic Test: Breath sampling · Procedure: Whole blood/ Plasma / serum sampling · Diagnostic Test: Headspace analysis for biological material
Patients with histologically confirmed oncological diseases, excluding gastric, colorectal, pancreatic and primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material
Diagnostic Test: Breath sampling · Procedure: Whole blood/ Plasma / serum sampling · Procedure: Histological examination of surgical specimen · Diagnostic Test: Headspace analysis for biological material
VOC will be detected in breath with off-line and on-line testing and in skin headspace with off-line testing
Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose)
Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for microbiota testing
Colonoscopy with proper biopsy or polypectomy material work-up will be used for identification and stratification of colorectal lesions as well as acquisition of biopsies for microbiota testing
Whole blood/Plasma/serum sampling will be used to obtain information for group stratification
Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Routine histological exam for patients undergoing curative or palliative surgery. Indication for surgery are set based on underlying condition. Study does not interfere with decision making for surgical treatment
VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc.
Specific VOC detected
Tuberculosis specific VOC detected in breath and in skin headspace
Time frame: 2 years
Performance of nanoarray sensor testing to detect target lesions and diseases
Sensitivity, specificity, overall accuracy of nanoarray sensor testing for VOCs to detect the target lesions in the blinded analysis
Time frame: At the time of breath sampling
Specific VOC patterns for target disease or lesion and risk groups
List of VOCs assayed by GC-MS with statistical difference between the study groups
Time frame: At the time of breath sampling
VOC pattern changes following treatment
VOC pattern changes after specific required treatment (medical eradication of bacteria/viruses, surgery/endoscopic removal for cancers or high risk lesion)
Time frame: At baseline, 3 and/or 6 months after treatment (other time frame according to study group)
VOC pattern changes in relapse of disease for early recognition and treatment
VOC pattern changes at the time of surveillance in case of relapse (malignant diseases).
Time frame: At baseline, 3 and/or 6 months after treatment (other time frame according to study group)
Groups of gastrointestinal microbiota correlating to VOCs
List of gastrointestinal microbiota groups (phylum/genus level) with positive correlation to particular VOCs
Time frame: At the time of sampling
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