Volatiles in Breath and Headspace Analysis - Diagnostic Markers

NCT03228095 | Unknown

• 1 other identifier: 2017/20329
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Volatile Organic Compounds; Tuberculosis; Nano-sensors; Electronic nose; Digestive cancers

Outcome Measures

Primary Outcomes (2)

• Specific VOC detected

  Tuberculosis specific VOC detected in breath and in skin headspace

  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

  At the time of breath sampling

Secondary Outcomes (4)

• Specific VOC patterns for target disease or lesion and risk groups

  At the time of breath sampling

• VOC pattern changes following treatment

  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

  At baseline, 3 and/or 6 months after treatment (other time frame according to study group)

• Groups of gastrointestinal microbiota correlating to VOCs

  At the time of sampling

Study Arms (17)

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; Diagnostic Test: Breath sampling; Procedure: Whole blood/ Plasma / serum sampling; Diagnostic Test: Headspace analysis for biological material

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; Diagnostic Test: Breath sampling; Procedure: Whole blood/ Plasma / serum sampling; Diagnostic Test: Headspace analysis for biological material

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; 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

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; 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

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; 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

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; Procedure: Upper endoscopy with biopsies; Procedure: Whole blood/ Plasma / serum sampling; Diagnostic Test: Faecal sampling; Diagnostic Test: Headspace analysis for biological material

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; 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

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; 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

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; 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

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; Procedure: Colonoscopy with biopsies; Procedure: Whole blood/ Plasma / serum sampling; Diagnostic Test: Faecal sampling; Diagnostic Test: Headspace analysis for biological material

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; Procedure: Whole blood/ Plasma / serum sampling; Diagnostic Test: Faecal sampling; Diagnostic Test: Headspace analysis for biological material

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; Procedure: Whole blood/ Plasma / serum sampling; Procedure: Histological examination of surgical specimen; Diagnostic Test: Headspace analysis for biological material

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; Procedure: Whole blood/ Plasma / serum sampling; Diagnostic Test: Headspace analysis for biological material

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; Procedure: Whole blood/ Plasma / serum sampling; Procedure: Histological examination of surgical specimen; Diagnostic Test: Headspace analysis for biological material

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; Procedure: Whole blood/ Plasma / serum sampling; Diagnostic Test: Headspace analysis for biological material

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; Procedure: Whole blood/ Plasma / serum sampling; Diagnostic Test: Headspace analysis for biological material

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; Procedure: Whole blood/ Plasma / serum sampling; Procedure: Histological examination of surgical specimen; Diagnostic Test: Headspace analysis for biological material

Interventions

VOC detection in breath and in skin headspace DIAGNOSTIC_TEST

VOC will be detected in breath with off-line and on-line testing and in skin headspace with off-line testing

Active Tuberculosis; Group of Control (Tuberculosis)

Breath sampling DIAGNOSTIC_TEST

Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose)

Active Tuberculosis; Average risk general population; Chronic liver disease; Chronic pancreatitis; Colorectal cancer; Colorectal high-risk lesions; Colorectal low-risk adenoma; Gastric cancer; Gastric dysplasia; Group of Control (Tuberculosis); Group of control (colorectal); High-risk gastric lesions; Liver cancer; Normal and low-risk gastric lesions; Oncological diseases of other locations; Pancreatic cancer; Upper respiratory tract acute infections

Upper endoscopy with biopsies PROCEDURE

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

Gastric cancer; Gastric dysplasia; High-risk gastric lesions; Normal and low-risk gastric lesions

Colonoscopy with biopsies PROCEDURE

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 cancer; Colorectal high-risk lesions; Colorectal low-risk adenoma; Group of control (colorectal)

Whole blood/ Plasma / serum sampling PROCEDURE

Whole blood/Plasma/serum sampling will be used to obtain information for group stratification

Active Tuberculosis; Average risk general population; Chronic liver disease; Chronic pancreatitis; Colorectal cancer; Colorectal high-risk lesions; Colorectal low-risk adenoma; Gastric cancer; Gastric dysplasia; Group of Control (Tuberculosis); Group of control (colorectal); High-risk gastric lesions; Liver cancer; Normal and low-risk gastric lesions; Oncological diseases of other locations; Pancreatic cancer; Upper respiratory tract acute infections

Faecal sampling DIAGNOSTIC_TEST

Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis

Average risk general population; Colorectal cancer; Colorectal high-risk lesions; Colorectal low-risk adenoma; Gastric cancer; Gastric dysplasia; Group of control (colorectal); High-risk gastric lesions; Normal and low-risk gastric lesions

Histological examination of surgical specimen PROCEDURE

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

Colorectal cancer; Colorectal high-risk lesions; Colorectal low-risk adenoma; Gastric cancer; Gastric dysplasia; High-risk gastric lesions; Liver cancer; Oncological diseases of other locations; Pancreatic cancer

Headspace analysis for biological material DIAGNOSTIC_TEST

VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc.

Active Tuberculosis; Average risk general population; Chronic liver disease; Chronic pancreatitis; Colorectal cancer; Colorectal high-risk lesions; Colorectal low-risk adenoma; Gastric cancer; Gastric dysplasia; Group of Control (Tuberculosis); Group of control (colorectal); High-risk gastric lesions; Liver cancer; Normal and low-risk gastric lesions; Oncological diseases of other locations; Pancreatic cancer; Upper respiratory tract acute infections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• Informed Consent not signed

Sponsors & Collaborators

• University of Latvia: lead
• Technion, Israel Institute of Technology: collaborator
• Riga East University Hospital: collaborator
• JLM Innovation GmbH: collaborator

Study Sites (1)

University of Latvia

Riga, LV 1586, Latvia

Location

Related Publications (3)

• Nakhleh MK, Amal H, Jeries R, Broza YY, Aboud M, Gharra A, Ivgi H, Khatib S, Badarneh S, Har-Shai L, Glass-Marmor L, Lejbkowicz I, Miller A, Badarny S, Winer R, Finberg J, Cohen-Kaminsky S, Perros F, Montani D, Girerd B, Garcia G, Simonneau G, Nakhoul F, Baram S, Salim R, Hakim M, Gruber M, Ronen O, Marshak T, Doweck I, Nativ O, Bahouth Z, Shi DY, Zhang W, Hua QL, Pan YY, Tao L, Liu H, Karban A, Koifman E, Rainis T, Skapars R, Sivins A, Ancans G, Liepniece-Karele I, Kikuste I, Lasina I, Tolmanis I, Johnson D, Millstone SZ, Fulton J, Wells JW, Wilf LH, Humbert M, Leja M, Peled N, Haick H. Diagnosis and Classification of 17 Diseases from 1404 Subjects via Pattern Analysis of Exhaled Molecules. ACS Nano. 2017 Jan 24;11(1):112-125. doi: 10.1021/acsnano.6b04930. Epub 2016 Dec 21.

  PMID: 28000444 BACKGROUND

• Xu ZQ, Broza YY, Ionsecu R, Tisch U, Ding L, Liu H, Song Q, Pan YY, Xiong FX, Gu KS, Sun GP, Chen ZD, Leja M, Haick H. A nanomaterial-based breath test for distinguishing gastric cancer from benign gastric conditions. Br J Cancer. 2013 Mar 5;108(4):941-50. doi: 10.1038/bjc.2013.44.

  PMID: 23462808 BACKGROUND

• Amal H, Leja M, Broza YY, Tisch U, Funka K, Liepniece-Karele I, Skapars R, Xu ZQ, Liu H, Haick H. Geographical variation in the exhaled volatile organic compounds. J Breath Res. 2013 Dec;7(4):047102. doi: 10.1088/1752-7155/7/4/047102. Epub 2013 Nov 1.

  PMID: 24184568 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Surgery and biopsy material as well as blood samples will contain himan DNA

MeSH Terms

Conditions

Tuberculosis; Stomach Neoplasms; Peptic Ulcer; Gastritis, Atrophic; Colorectal Neoplasms; Pancreatic Neoplasms; Pancreatitis, Chronic; Liver Neoplasms; Liver Cirrhosis; Influenza, Human; Inflammatory Bowel Diseases; Gastrointestinal Neoplasms

Interventions

Gastroscopy; Biopsy; Colonoscopy

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Duodenal Diseases; Intestinal Diseases; Gastritis; Gastroenteritis; Intestinal Neoplasms; Colonic Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Fibrosis; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques

Study Officials

• Mārcis Leja, PhD, MD

  University of Latvia

  STUDY DIRECTOR

• Lelde Lauka, MD

  University of Latvia

  PRINCIPAL INVESTIGATOR

• Andra Cīrule, MD

  Riga East University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 24, 2017
• Study Start: July 24, 2017
• Primary Completion: December 20, 2019
• Study Completion: December 31, 2025
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

LA (1)