Volatile Markers in Digestive Cancer

CompletedOBSERVATIONAL
Enrollment

2,022

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
Colorectal CancerColorectal AdenomaGastric CancerPeptic Ulcer DiseaseAtrophic GastritisIntestinal MetaplasiaH.Pylori InfectionNormal ControlAverage-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)

Trial Locations (2)

LV 1586

University of Latvia, Riga

LT 44307

Lithuanian University of Health Sciences, Kaunas

All Listed Sponsors
collaborator

Technion, Israel Institute of Technology

OTHER

collaborator

Lithuanian University of Health Sciences

OTHER

collaborator

Karolinska Institutet

OTHER

collaborator

German Cancer Research Center

OTHER

collaborator

Digestive Diseases Centre GASTRO

OTHER

collaborator

Riga East Clinical University Hospital

OTHER_GOV

collaborator

Academic Histology Laboratory (Latvia)

OTHER

collaborator

JLM Innovation GmbH (Germany)

UNKNOWN

lead

University of Latvia

OTHER

NCT02332213 - Volatile Markers in Digestive Cancer | Biotech Hunter | Biotech Hunter