Volatile Markers in Digestive Cancer

Summary

The study is aimed to determine the potential of volatile marker testing for identification of gastrointestinal cancers (in particular - colorectal and gastric cancers), the related precancerous lesions in the stomach and colon.

The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.

Conditions

• Colorectal Cancer
• Colorectal Adenoma
• Gastric Cancer
• Peptic Ulcer Disease
• Atrophic Gastritis
• Intestinal Metaplasia
• H.Pylori Infection
• Normal Control
• Average-risk General Population

Interventions

PROCEDURE

Breath sampling for volatile marker detection

Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology

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

PROCEDURE

Colonoscopy with biopsies or lesion removal when required

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

PROCEDURE

Plasma/serum sampling

Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination

PROCEDURE

Faecal sample acquisition

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

PROCEDURE

Histological evaluation of the surgery material

The material obtained during surgery (stomach or colorectal) will be used for confirmation of the diagnosis in cancer groups. Surgery itself will be performed according to the clinical indications, and will not be extended (i.e. cannot be considered a study intervention)

Sponsors & Collaborators

• Technion, Israel Institute of Technology

  collaborator OTHER

• Lithuanian University of Health Sciences

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• German Cancer Research Center

  collaborator OTHER

• Digestive Diseases Centre GASTRO

  collaborator OTHER

• Riga East Clinical University Hospital

  collaborator OTHER_GOV

• Academic Histology Laboratory (Latvia)

  collaborator OTHER

• JLM Innovation GmbH (Germany)

  collaborator UNKNOWN

• University of Latvia

  lead OTHER

Principal Investigators

• Hossam Haick, Ph.D. · Technion, Israel Institute for Technology (Israel)

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2017-06-30

Completion

2017-06-30

Countries

• Latvia
• Lithuania

Study Locations