Volatile Markers in Digestive Cancer (VOLGACORE)

University of Latvia

Status

Completed

Conditions

Atrophic Gastritis

Peptic Ulcer Disease

Colorectal Adenoma

Gastric Cancer

Intestinal Metaplasia

Average-risk General Population

H.Pylori Infection

Normal Control

Colorectal Cancer

Treatments

Procedure: Colonoscopy with biopsies or lesion removal when required

Procedure: Faecal sample acquisition

Procedure: Plasma/serum sampling

Procedure: Upper endoscopy with biopsies

Procedure: Breath sampling for volatile marker detection

Procedure: Histological evaluation of the surgery material

Study type

Observational

Funder types

Other

Identifiers

NCT02332213

2914

LZP Nr. 2014.10-5 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Patients with established disease (cancer, precancerous lesions) as well as patients investigated for the lesions and having been documented lack of the lesions will be enrolled to the study at clinical sites in Europe (Latvia, Lithuania). In addition, group of persons from general population at average risk for developing the target disease will be also enrolled.

Testing of volatile markers will be conducted by one of two methods: 1) gas chromatography coupled to mass spectroscopy (GS-MS) and 2) nanosensor technology.

Volunteers (including patients with established disease) will be enrolled prior the removal of the target lesion (e.g. surgery for cancer or polypectomy in the case of a polyp).

The study will be conducted by utilizing the experience of institutions in the European Union and Israel.

Enrollment

2,022 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients with verifies colorectal cancer (Group 1)
Patients with verified gastric cancer (Group 5)
Patients undergoing colonoscopy due to clinical indications (group 2-4)
Patients undergoing upper endoscopy due to clinical indications (Group 6-8)
Average-risk population group aged 40-64 at inclusion without alarm symptoms (Group 9)
Motivation to participate in the study
Physical status allowing volatile marker sampling and other procedures within the protocol
Signed consent

Exclusion criteria

Known other active cancer
Ventilation problems, airway obstruction
Unwillingness or inability to co-operate

Trial design

2,022 participants in 9 patient groups

1. Colorectal cancer

Description:

Patients with histologically confirmed colorectal cancer (adenocarcinoma)

Treatment:

Procedure: Colonoscopy with biopsies or lesion removal when required

Procedure: Plasma/serum sampling

Procedure: Histological evaluation of the surgery material

Procedure: Breath sampling for volatile marker detection

Procedure: Faecal sample acquisition

2. 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.

Treatment:

Procedure: Colonoscopy with biopsies or lesion removal when required

Procedure: Plasma/serum sampling

Procedure: Breath sampling for volatile marker detection

Procedure: Faecal sample acquisition

3. Colorectal low-risk adenoma

Description:

Patients without colorectal adenocarcinoma and without colorectal high-risk lesions as described under Group 2 criteria

Treatment:

Procedure: Colonoscopy with biopsies or lesion removal when required

Procedure: Plasma/serum sampling

Procedure: Breath sampling for volatile marker detection

Procedure: Faecal sample acquisition

4. Group of control (colorectal)

Description:

Patients having undergone colonoscopy without an evidence for colorectal lesions fulfilling Group 1 or Group 2 or Group 3 criteria. Prior to removal of the lesions.

Treatment:

Procedure: Colonoscopy with biopsies or lesion removal when required

Procedure: Plasma/serum sampling

Procedure: Breath sampling for volatile marker detection

Procedure: Faecal sample acquisition

5. Gastric cancer

Description:

Patients with histologically confirmed gastric cancer (adenocarcinoma)

Treatment:

Procedure: Plasma/serum sampling

Procedure: Upper endoscopy with biopsies

Procedure: Histological evaluation of the surgery material

Procedure: Breath sampling for volatile marker detection

Procedure: Faecal sample acquisition

6. Gastric dysplasia

Description:

Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach

Treatment:

Procedure: Plasma/serum sampling

Procedure: Upper endoscopy with biopsies

Procedure: Breath sampling for volatile marker detection

Procedure: Faecal sample acquisition

7. High-risk gastric lesions

Description:

Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, but excluding those with dysplasia (Group 5)

Treatment:

Procedure: Plasma/serum sampling

Procedure: Upper endoscopy with biopsies

Procedure: Breath sampling for volatile marker detection

Procedure: Faecal sample acquisition

8. Normal and low-risk gastric lesions

Description:

Staged 0-III according to OLGIM. Dysplasia should be excluded

Treatment:

Procedure: Plasma/serum sampling

Procedure: Upper endoscopy with biopsies

Procedure: Breath sampling for volatile marker detection