Hybrid-sensor Breath Analysis for Colorectal Cancer Screening

Summary

The aim of this project is to promote the breath volatile marker concept for colorectal cancer (CRC) screening by advancing developing the application of a novel hybrid analyzer for the purpose.

The hybrid analyzer concept is expected to benefit of combining metal-oxide (MOX) and infrared spectrum (IR) sensor acquired data. The current study will be the first globally to address this concept in CRC detection. In addition, traditional methods, in particular, gas chromatography coupled to mass spectrometry (GC-MS) will be used to address the biological relevance of the VOCs emission from cancer tissue and will assist in further advances of the hybrid-sensing approach.

Conditions

• Colorectal Cancer
• Polyp of Colon

Interventions

PROCEDURE

Identification of specific VOCs in CRC tissue surgery material

Paired tissue samples will be taken during surgery for CRC. Tissue material from the same patient will be obtained from the cancerous tissue as well as from normal resected material without malignant infiltration. Minimum of 100 mg of each tissue per sample will be obtained. To compare the emission of VOCs in the CRC tissue surgery material to the emissions from normal tissue by GC-MS in a reasonable number of cancer cases.

OTHER

Secondary validation study in general CRC screening settings

Altogether at least 1000 individuals relatively healthy 40-64 years old population-based collected individuals will get recruited. Breath samples will be collected by asking the study subjects to breath into hybrid breath analyser. To exclude significant colorectal lesions, laboratory-based FIT testing will be offered to the population cohort group for faecal occult blood in faeces. Serum and plasma samples will also be obtained to have them available if additional testing will be required. Individuals with a FIT test value over the cut-off value (\>10 microg/g faeces) will be invited to colonoscopy. The data analysis procedures and classification models will be tested in this general population and cross-checked against FIT and colonoscopy results.

DEVICE

Breath sampling for VOC detection

Breath sampling will be performed by using a hybrid sensor device and or GC-MS analysis (by collecting breath samples in adsorbent tubes). Strict requirements for subjects will be imposed prior to the breath sampling to standardise the breath sampling and to limit the influence of confounding factors.

OTHER

Blood sample collection

Serum, plasma sampling for group description and stratification.

DIAGNOSTIC_TEST

Microbiota testing

Faecal samples for microbiota testing.

DIAGNOSTIC_TEST

Colonoscopy

Colonoscopy will be used only according to the clinical indications.

Sponsors & Collaborators

• Universitaet Innsbruck

  collaborator OTHER

• University of Ulm

  collaborator OTHER

• University of Latvia

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-01

Primary Completion

2023-11-30

Completion

2023-11-30

Countries

• Latvia

Study Locations