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NCT Number: NCT02332213

Volatile Markers in Digestive Cancer

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.

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Key information

Conditions

Colorectal Cancer Adenoma Atrophic Gastritis Average-risk General Population Colonic Diseases Colorectal Adenoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Gastric Cancer Gastritis Gastritis, Atrophic Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms H.Pylori Infection Intestinal Diseases Intestinal Metaplasia Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Normal Control Peptic Ulcer Peptic Ulcer Disease Rectal Diseases Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Latvia, Riga, Latvia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breath sampling for volatile marker detection

Procedure

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

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

Colonoscopy with biopsies or lesion removal when required

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

Plasma/serum sampling

Procedure

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

Faecal sample acquisition

Procedure

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

Histological evaluation of the surgery material

Procedure

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)

Primary outcomes

  1. Performance of nanoarray sensor testing to detect target lesions

    Time frame: At the time of breath sampling

    Sensitivity, specificity, overall accuracy of nanoarray sensor testing for VOCs to detect the target lesions in the blinded analysis

  2. VOCs differentiating the study groups

    Time frame: At the time of breath sampling

    List of VOCs assayed by GC-MS with statistical difference between the study groups

Secondary outcomes

  1. Identification of characteristic VOC pattern in risk age groups

    Time frame: At the time of sampling

    List of characteristic VOCs in general population at risk for developing gastrointestinal cancer, including analysis of confounding factors, e.g. dietary habits, smoking, and profession.

  2. VOC pattern changes following treatment

    Time frame: At baseline and every 6 months within 3 year period

    Significant change in VOC content before and following treatment (surgery, medical therapy, combined)

  3. Groups of gastrointestinal microbiota correlating to VOCs

    Time frame: At the time of sampling

    List of gastrointestinal microbiota groups (phylum/genus level) with positive correlation to particular VOCs

Other outcomes

  1. VOC pattern changes following intervention to microbiota

    Time frame: At baseline and following the intervention (1 week, 1 month)

    Significant change in VOC content before and following intervention upon microbiome (antibiotic intake, colon cleansing)

  2. Gastric microbiome changes following intervention to microbiota

    Time frame: At baseline and 3 years after intervention

    Significant change in gastric microbiome (phyla, genera) before and following intervention upon microbiome (antibiotic intake)

  3. Gastrointestinal microbiome in cancer patients

    Time frame: At the time of sampling

    Significant differences in the composition of gastric and colonic microbiome (phyla, genera) in cancer patients, patients with precancerous lesions and controls

Sponsors and collaborators

Lead sponsor

University of Latvia

Other

Collaborators

  • Academic Histology Laboratory (Latvia)
  • Digestive Diseases Centre GASTRO
  • German Cancer Research Center
  • JLM Innovation GmbH (Germany)
  • Karolinska Institutet
  • Lithuanian University of Health Sciences
  • Riga East Clinical University Hospital
  • Technion, Israel Institute of Technology

Registry information

Official study title

Volatile Marker Testing for Digestive Cancer and Precancerous Lesion Detection, Evaluation of Confounding Factors

Acronym: VOLGACORE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2015
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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