Clinical trial NCT02332213: Volatile Markers in Digestive Cancer
Official title: Volatile Marker Testing for Digestive Cancer and Precancerous Lesion Detection, Evaluation of Confounding Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Colorectal Adenoma
Gastric Cancer
Peptic Ulcer Disease
Atrophic Gastritis
Intestinal Metaplasia
H.Pylori Infection
Normal Control
Average-risk General Population
Keywords: Volatile organic compounds
Nanosensor technology
GC-MS
Breath-testing
Digestive cancer
Precancerous lesions
Colorectal cancer
Adenoma
Gastric cancer
Atrophic gastritis
OLGIM
Lead sponsor: University of Latvia
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
name: Lithuanian University of Health Sciences
name: Karolinska Institutet
name: German Cancer Research Center
name: Digestive Diseases Centre GASTRO
name: Riga East Clinical University Hospital
name: Academic Histology Laboratory (Latvia)
name: JLM Innovation GmbH (Germany)
First posted: 2015-01-06
Enrollment: 2022
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients (Group 1 and 5) will be predominantly enrolled at the time scheduled for surgery, however also patients undergoing diagnostic procedures (endoscopy) will be eligible

Patients without malignant disease but defined colorectal (Groups 2-4) status will be predominantly enrolled prior colonoscopy in out-patient settings. Sampling starting from 1 week after colonoscopy will be allowed if the lesions will not get removed during the index endoscopy

Patients without malignant disease but defined gastric mucosal status (Groups 6-8) status will be predominantly enrolled prior upper endoscopy in out-patient settings. Sampling starting from 2 days after upper endoscopy will be allowed if the lesions will not get removed during the index endoscopy

Average cancer risk subjects (Group 9) will get enrolled by inviting individuals predominantly selected from the lists of general practitioners.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance of nanoarray sensor testing to detect target lesions
timeFrame: At the time of breath sampling
measure: VOCs differentiating the study groups
timeFrame: At the time of breath sampling
Secondary outcomes:
measure: Identification of characteristic VOC pattern in risk age groups
timeFrame: At the time of sampling
measure: VOC pattern changes following treatment
timeFrame: At baseline and every 6 months within 3 year period
measure: Groups of gastrointestinal microbiota correlating to VOCs
timeFrame: At the time of sampling
Other outcomes:
measure: VOC pattern changes following intervention to microbiota
timeFrame: At baseline and following the intervention (1 week, 1 month)
measure: Gastric microbiome changes following intervention to microbiota
timeFrame: At baseline and 3 years after intervention
measure: Gastrointestinal microbiome in cancer patients
timeFrame: At the time of sampling
Locations:
city: Riga
country: Latvia
facility: University of Latvia
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
affiliation: Technion, Israel Institute for Technology (Israel)
name: Hossam Haick, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.