ClinicalTrials.Veeva

Menu

Volatiles in Breath and Headspace Analysis - Diagnostic Markers (Volatolome)

U

University of Latvia

Status

Invitation-only

Conditions

Atrophic Gastritis
Peptic Ulcer
Colorectal Adenoma
Intestinal Metaplasia
Liver Cirrhosis
Pancreatitis, Chronic
Liver Cancer
Gastric Dysplasia
Other Infectious Diseases
Tuberculosis
Gastric Cancer
Colorectal Polyp
Inflammatory Bowel Diseases
Flu, Human
Pancreatic Cancer
Colorectal Cancer

Treatments

Diagnostic Test: Headspace analysis for biological material
Diagnostic Test: Breath sampling
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: VOC detection in breath and in skin headspace
Diagnostic Test: Faecal sampling
Procedure: Upper endoscopy with biopsies
Procedure: Histological examination of surgical specimen
Procedure: Colonoscopy with biopsies

Study type

Observational

Funder types

Other

Identifiers

NCT03228095
2017/20329

Details and patient eligibility

About

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

Full description

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.

Enrollment

3,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Informed Consent signed
  • Individual with targeted disease/lesion (tuberculosis, gastric cancer, gastric dysplasia, high/ normal/ low risk gastric lesions, colorectal cancer, high-risk colorectal lesions, low-risk colorectal adenoma, pancreatic cancer, chronic pancreatitis, liver cancer, chronic liver disease, other infectious diseases, oncological diseases of other location)

Exclusion criteria

  • Informed Consent not signed
  • Other active cancer at the time of inclusion for particular study group

Trial design

3,000 participants in 17 patient groups

Active Tuberculosis
Description:
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
Treatment:
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: VOC detection in breath and in skin headspace
Diagnostic Test: Headspace analysis for biological material
Diagnostic Test: Breath sampling
Group of Control (Tuberculosis)
Description:
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
Treatment:
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: VOC detection in breath and in skin headspace
Diagnostic Test: Headspace analysis for biological material
Diagnostic Test: Breath sampling
Gastric cancer
Description:
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
Treatment:
Procedure: Upper endoscopy with biopsies
Diagnostic Test: Faecal sampling
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Procedure: Histological examination of surgical specimen
Diagnostic Test: Breath sampling
Gastric dysplasia
Description:
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
Treatment:
Procedure: Upper endoscopy with biopsies
Diagnostic Test: Faecal sampling
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Procedure: Histological examination of surgical specimen
Diagnostic Test: Breath sampling
High-risk gastric lesions
Description:
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
Treatment:
Procedure: Upper endoscopy with biopsies
Diagnostic Test: Faecal sampling
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Procedure: Histological examination of surgical specimen
Diagnostic Test: Breath sampling
Normal and low-risk gastric lesions
Description:
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
Treatment:
Procedure: Upper endoscopy with biopsies
Diagnostic Test: Faecal sampling
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Diagnostic Test: Breath sampling
Colorectal cancer
Description:
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
Treatment:
Procedure: Colonoscopy with biopsies
Diagnostic Test: Faecal sampling
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Procedure: Histological examination of surgical specimen
Diagnostic Test: Breath sampling
Colorectal high-risk lesions
Description:
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
Treatment:
Procedure: Colonoscopy with biopsies
Diagnostic Test: Faecal sampling
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Procedure: Histological examination of surgical specimen
Diagnostic Test: Breath sampling
Colorectal low-risk adenoma
Description:
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
Treatment:
Procedure: Colonoscopy with biopsies
Diagnostic Test: Faecal sampling
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Procedure: Histological examination of surgical specimen
Diagnostic Test: Breath sampling
Group of control (colorectal)
Description:
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
Treatment:
Procedure: Colonoscopy with biopsies
Diagnostic Test: Faecal sampling
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Diagnostic Test: Breath sampling
Average risk general population
Description:
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
Treatment:
Diagnostic Test: Faecal sampling
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Diagnostic Test: Breath sampling
Pancreatic cancer
Description:
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
Treatment:
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Procedure: Histological examination of surgical specimen
Diagnostic Test: Breath sampling
Chronic pancreatitis
Description:
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
Treatment:
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Diagnostic Test: Breath sampling
Liver cancer
Description:
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
Treatment:
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Procedure: Histological examination of surgical specimen
Diagnostic Test: Breath sampling
Chronic liver disease
Description:
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
Treatment:
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Diagnostic Test: Breath sampling
Upper respiratory tract acute infections
Description:
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
Treatment:
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Diagnostic Test: Breath sampling
Oncological diseases of other locations
Description:
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
Treatment:
Procedure: Whole blood/ Plasma / serum sampling
Diagnostic Test: Headspace analysis for biological material
Procedure: Histological examination of surgical specimen
Diagnostic Test: Breath sampling

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems