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

August 20, 2018 updated by: University of Latvia

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 Overview

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Latvia
- - Riga, Latvia, LV 1586
    - University of Latvia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients being referred for diagnostic testing and treatment Healthy individuals from general population

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific VOC detected Time Frame: 2 years	Tuberculosis specific VOC detected in breath and in skin headspace	2 years
Performance of nanoarray sensor testing to detect target lesions and diseases Time Frame: At the time of breath sampling	Sensitivity, specificity, overall accuracy of nanoarray sensor testing for VOCs to detect the target lesions in the blinded analysis	At the time of breath sampling

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific VOC patterns for target disease or lesion and risk groups Time Frame: At the time of breath sampling	List of VOCs assayed by GC-MS with statistical difference between the study groups	At the time of breath sampling
VOC pattern changes following treatment Time Frame: At baseline, 3 and/or 6 months after treatment (other time frame according to study group)	VOC pattern changes after specific required treatment (medical eradication of bacteria/viruses, surgery/endoscopic removal for cancers or high risk lesion)	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 Time Frame: At baseline, 3 and/or 6 months after treatment (other time frame according to study group)	VOC pattern changes at the time of surveillance in case of relapse (malignant diseases).	At baseline, 3 and/or 6 months after treatment (other time frame according to study group)
Groups of gastrointestinal microbiota correlating to VOCs Time Frame: At the time of sampling	List of gastrointestinal microbiota groups (phylum/genus level) with positive correlation to particular VOCs	At the time of sampling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Latvia

Collaborators

Technion, Israel Institute of Technology

Riga East University Hospital

JLM Innovation GmbH

Investigators

Study Director: Mārcis Leja, PhD, MD, University of Latvia
Principal Investigator: Lelde Lauka, MD, University of Latvia
Principal Investigator: Andra Cīrule, MD, Riga East University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 24, 2017

Primary Completion (ANTICIPATED)

December 20, 2019

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

July 21, 2017

First Submitted That Met QC Criteria

July 21, 2017

First Posted (ACTUAL)

July 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

2017/20329

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Cirrhosis

Postgraduate Institute of Medical Education and...
Society for the Study of Liver Diseases, Chandigarh ( India )

Unknown

GCSF Therapy in Decompensated Cirrhosis - A Double Blinded RCT

Decompensated Cirrhosis of Liver

India
The Second Affiliated Hospital of Chongqing Medical...

Recruiting

Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis.

Fibrosis, Liver | Cirrhosis, Liver

China
SUUMC Central Military Hospital Dr Carol Davila

Recruiting

Nutritional Assesment in Patients With Cirrhosis

Cirrhosis, Liver

Romania
The Cleveland Clinic

Recruiting

HMB Enriched Amino Acids to Reverse Muscle Loss in Cirrhosis

Cirrhosis, Liver

United States
The Cleveland Clinic

Recruiting

Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis

Cirrhosis, Liver

United States
University of Pittsburgh
National Institute on Drug Abuse (NIDA)

Completed

Improving Pain Management and Opioid Safety for Patients With Cirrhosis

Cirrhosis, Liver

United States
University of Oulu

Suspended

4beta-hydroxycholesterol in Cirrhosis

Cirrhosis, Liver

Finland
Beth Israel Deaconess Medical Center
American Association for the Study of Liver Diseases Foundation

Completed

Prophylactic Antibiotics in Admitted Cirrhotics

Cirrhosis, Liver

United States
Asian Institute of Gastroenterology, India

Completed

Combination of Autologous MSC and HSC Infusion in Patients With Decompensated Cirrhosis

Cirrhosis, Liver

India
Sherief Abd-Elsalam

Unknown

Propofol Versus Midazolam for Lower Gastrointestinal Endoscopy

Cirrhosis, Liver

Egypt

Clinical Trials on VOC detection in breath and in skin headspace

University of Latvia
Uppsala University; Pontificia Universidad Catolica de Chile; Technion, Israel... and other collaborators

Recruiting

Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach (VOGAS)

Gastric Cancer | Gastric Dysplasia | Atrophic Gastritis | H.Pylori Infection

Brazil, Chile, Colombia, Latvia, Ukraine
University of Latvia
University of Ulm; Universitaet Innsbruck

Recruiting

Hybrid-sensor Breath Analysis for Colorectal Cancer Screening (HYCOR)

Colorectal Cancer | Polyp of Colon

Latvia
RenJi Hospital
Ruijin Hospital

Completed

Association of Carbamylated HDL and CAD in T2DM Patients

Type 2 Diabetes Mellitus With Circulatory Complciation

China
Tilburg University
GGZ Breburg

Not yet recruiting

Psychoeducation for Older Adults With Autism (OPAS)

Autism Spectrum Disorder

Netherlands
Assistance Publique - Hôpitaux de Paris
Société ADEMTECH SA

Completed

Prospective Multicenter Evaluation of the MycoGenie Kit for the Diagnosis of Invasive Aspergillosis (MYCOGENIE)

Invasive Aspergillosis in Patients With Onco-haematological Diseases

France
Assistance Publique - Hôpitaux de Paris
Hoffmann-La Roche

Completed

Diagnosis of Septicaemia by Detection of Microbial DNA in Blood in Severe Infections (EVAMICA)

Febrile Neutropenia | Severe Sepsis | Endocarditis

France
Universitaire Ziekenhuizen KU Leuven

Completed

I-Scan For Colon Polyp Detection In HNPCC

Lynch Syndrome | Hereditary Non-polyposis Colon Carcinoma | HNPCC

Belgium
University Hospital, Limoges

Not yet recruiting

Three-min Step Test and Exercise Desaturation Detection in Chronic Respiratory Insufficiency Patients (STEPSAT)

COPD | Chronic Respiratory Disease
Lund University Hospital

Recruiting

Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome. (BIO-MUSE)

Mycosis Fungoides | Sezary Syndrome

Sweden
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Enrolling by invitation

Measurements of Water in Breath and Saliva

Human Energy Expenditure

United States

Group / Cohort	Intervention / Treatment
Active Tuberculosis 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 VOC will be detected in breath with off-line and on-line testing and in skin headspace with off-line testing Diagnostic test: Breath sampling Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc.
Group of Control (Tuberculosis) 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 VOC will be detected in breath with off-line and on-line testing and in skin headspace with off-line testing Diagnostic test: Breath sampling Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc.
Gastric cancer 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc. Procedure: Upper endoscopy with biopsies 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 Diagnostic test: Faecal sampling Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis Procedure: Histological examination of surgical specimen 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
Gastric dysplasia 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc. Procedure: Upper endoscopy with biopsies 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 Diagnostic test: Faecal sampling Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis Procedure: Histological examination of surgical specimen 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
High-risk gastric lesions 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc. Procedure: Upper endoscopy with biopsies 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 Diagnostic test: Faecal sampling Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis Procedure: Histological examination of surgical specimen 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
Normal and low-risk gastric lesions 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc. Procedure: Upper endoscopy with biopsies 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 Diagnostic test: Faecal sampling Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Colorectal cancer 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc. Diagnostic test: Faecal sampling Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis Procedure: Histological examination of surgical specimen 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 Procedure: Colonoscopy with biopsies 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
Colorectal high-risk lesions 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc. Diagnostic test: Faecal sampling Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis Procedure: Histological examination of surgical specimen 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 Procedure: Colonoscopy with biopsies 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
Colorectal low-risk adenoma 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc. Diagnostic test: Faecal sampling Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis Procedure: Histological examination of surgical specimen 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 Procedure: Colonoscopy with biopsies 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
Group of control (colorectal) 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc. Diagnostic test: Faecal sampling Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis Procedure: Colonoscopy with biopsies 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
Average risk general population 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc. Diagnostic test: Faecal sampling Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Pancreatic cancer 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc. Procedure: Histological examination of surgical specimen 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
Chronic pancreatitis 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc.
Liver cancer 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc. Procedure: Histological examination of surgical specimen 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
Chronic liver disease 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc.
Upper respiratory tract acute infections 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc.
Oncological diseases of other locations 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 Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose) Procedure: Whole blood/ Plasma / serum sampling Whole blood/Plasma/serum sampling will be used to obtain information for group stratification Diagnostic test: Headspace analysis for biological material VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc. Procedure: Histological examination of surgical specimen 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