Volatile Markers in Digestive Cancer

Colorectal Cancer Clinical Trial

— VOLGACORE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332213
• Other study ID #: 2914
• Secondary ID: LZP Nr. 2014.10-
• Status: Completed
• Start date: January 2014
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2018
• Source: University of Latvia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2022
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Breath sampling for volatile marker detection
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
• 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
• 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
• Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
• Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
• 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)

Locations

Country	Name	City	State
Latvia	University of Latvia	Riga
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (9)

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

Countries where clinical trial is conducted

Latvia,  Lithuania, 

References & Publications (3)

Amal H, Leja M, Broza YY, Tisch U, Funka K, Liepniece-Karele I, Skapars R, Xu ZQ, Liu H, Haick H. Geographical variation in the exhaled volatile organic compounds. J Breath Res. 2013 Dec;7(4):047102. doi: 10.1088/1752-7155/7/4/047102. Epub 2013 Nov 1. — View Citation

Haick H, Broza YY, Mochalski P, Ruzsanyi V, Amann A. Assessment, origin, and implementation of breath volatile cancer markers. Chem Soc Rev. 2014 Mar 7;43(5):1423-49. doi: 10.1039/c3cs60329f. Epub 2013 Dec 4. Review. — View Citation

Xu ZQ, Broza YY, Ionsecu R, Tisch U, Ding L, Liu H, Song Q, Pan YY, Xiong FX, Gu KS, Sun GP, Chen ZD, Leja M, Haick H. A nanomaterial-based breath test for distinguishing gastric cancer from benign gastric conditions. Br J Cancer. 2013 Mar 5;108(4):941-50. doi: 10.1038/bjc.2013.44. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VOC pattern changes following intervention to microbiota	Significant change in VOC content before and following intervention upon microbiome (antibiotic intake, colon cleansing)	At baseline and following the intervention (1 week, 1 month)
Other	Gastric microbiome changes following intervention to microbiota	Significant change in gastric microbiome (phyla, genera) before and following intervention upon microbiome (antibiotic intake)	At baseline and 3 years after intervention
Other	Gastrointestinal microbiome in cancer patients	Significant differences in the composition of gastric and colonic microbiome (phyla, genera) in cancer patients, patients with precancerous lesions and controls	At the time of sampling
Primary	Performance of nanoarray sensor testing to detect target lesions	Sensitivity, specificity, overall accuracy of nanoarray sensor testing for VOCs to detect the target lesions in the blinded analysis	At the time of breath sampling
Primary	VOCs differentiating the study groups	List of VOCs assayed by GC-MS with statistical difference between the study groups	At the time of breath sampling
Secondary	Identification of characteristic VOC pattern in risk age groups	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.	At the time of sampling
Secondary	VOC pattern changes following treatment	Significant change in VOC content before and following treatment (surgery, medical therapy, combined)	At baseline and every 6 months within 3 year period
Secondary	Groups of gastrointestinal microbiota correlating to VOCs	List of gastrointestinal microbiota groups (phylum/genus level) with positive correlation to particular VOCs	At the time of sampling