Hybrid-sensor Breath Analysis for Colorectal Cancer Screening
NCT ID: NCT05173077
Last Updated: 2022-02-15
Study Results
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Basic Information
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UNKNOWN
3000 participants
OBSERVATIONAL
2022-02-01
2023-11-30
Brief Summary
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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.
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Detailed Description
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1. To identify cancer-related VOCs emitted by the CRC tissue via the comparison of VOCs emitted from cancer tissue with VOCs emitted by non-cancerous tissue (ex vivo surgery material) by GC-MS.
2. To identify the VOCs differentiating human breath from CRC patients and controls (by GC-MS) as well as compare the chemical signature of CRC patients' breath to the chemical signature of cancer tissue.
3. To evaluate the performance of the set of sensors in the hybrid analyzer and the performance of particular sensors for detecting CRC; to develop and validate a mathematical model for CRC detection.
4. To validate the hybrid analyzer in real-life CRC screening settings, i.e. versus the generally accepted CRC screening approach of faecal occult blood detection.
5. To compare faecal microbiome between CRC group and control.
The scientific results to be obtained during the current project are expected to elucidate the origin and metabolism of volatile biomarkers of CRC. This achievement, in turn, will facilitate the implementation of a new screening test based on the newly developed hybrid analyser into medical practice.
Identification of the VOCs patterns by the sensor array for CRC patients when compared to controls. Addressing these objectives will allow an in-depth understanding of the physiological background for exhaled VOCs in CRC patients and facilitate the development of technologies able to identify the disease and its precursors from an exhaled breath sample.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Colorectal cancer patients
Patients with histologically confirmed colorectal cancer (adenocarcinoma)
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.
Blood sample collection
Serum, plasma sampling for group description and stratification.
Microbiota testing
Faecal samples for microbiota testing.
Control group patients without colorectal cancer
Patients without colorectal malignant disease according to data obtained in colonoscopy
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.
Blood sample collection
Serum, plasma sampling for group description and stratification.
Microbiota testing
Faecal samples for microbiota testing.
Colonoscopy
Colonoscopy will be used only according to the clinical indications.
Average risk population
Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer
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.
Blood sample collection
Serum, plasma sampling for group description and stratification.
Microbiota testing
Faecal samples for microbiota testing.
Colonoscopy
Colonoscopy will be used only according to the clinical indications.
Colorectal cancer patients undergoing surgery
Patients with histologically confirmed colorectal cancer (adenocarcinoma) planned for surgical management
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.
Blood sample collection
Serum, plasma sampling for group description and stratification.
Microbiota testing
Faecal samples for microbiota testing.
Patients with polyps undergoing polypectomy
Patients with colon polyps that will perform polypectomy
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.
Blood sample collection
Serum, plasma sampling for group description and stratification.
Microbiota testing
Faecal samples for microbiota testing.
Colonoscopy
Colonoscopy will be used only according to the clinical indications.
Interventions
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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.
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.
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.
Blood sample collection
Serum, plasma sampling for group description and stratification.
Microbiota testing
Faecal samples for microbiota testing.
Colonoscopy
Colonoscopy will be used only according to the clinical indications.
Eligibility Criteria
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Inclusion Criteria
* Having signed the consent form
* Willingness to collaborate
* Able to provide a breath sample
* For the cancer group: colorectal adenocarcinoma has to be documented histologically (histological diagnosis following gastric surgery is also accepted) or patients being confirmed adenocarcinoma during the course of the study.
* For the non-cancer group: control group - any patient who have medical indications for a colonoscopy
Exclusion Criteria
* Patients who have had a complete bowel cleansing
* Other active malignancies
* Neoadjuvant chemotherapy, radiation therapy is currently underway
* Acute conditions (emergency surgery for the patient)
* Small bowel resection in the past
* Terminal renal failure (Chronic renal failure stage 4)
* Type I diabetes
* Bronchial asthma (active)
18 Years
ALL
No
Sponsors
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Universitaet Innsbruck
OTHER
University of Ulm
OTHER
University of Latvia
OTHER
Responsible Party
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Marcis Leja
Director, Institute of Clinical and Preventive Medicine
Locations
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University of Latvia
Riga, , Latvia
Countries
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Central Contacts
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Facility Contacts
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References
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Arnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27.
Jurs PC, Bakken GA, McClelland HE. Computational methods for the analysis of chemical sensor array data from volatile analytes. Chem Rev. 2000 Jul 12;100(7):2649-78. doi: 10.1021/cr9800964. No abstract available.
van Keulen KE, Jansen ME, Schrauwen RWM, Kolkman JJ, Siersema PD. Volatile organic compounds in breath can serve as a non-invasive diagnostic biomarker for the detection of advanced adenomas and colorectal cancer. Aliment Pharmacol Ther. 2020 Feb;51(3):334-346. doi: 10.1111/apt.15622. Epub 2019 Dec 20.
Zhou W, Tao J, Li J, Tao S. Volatile organic compounds analysis as a potential novel screening tool for colorectal cancer: A systematic review and meta-analysis. Medicine (Baltimore). 2020 Jul 2;99(27):e20937. doi: 10.1097/MD.0000000000020937.
Sonoda H, Kohnoe S, Yamazato T, Satoh Y, Morizono G, Shikata K, Morita M, Watanabe A, Morita M, Kakeji Y, Inoue F, Maehara Y. Colorectal cancer screening with odour material by canine scent detection. Gut. 2011 Jun;60(6):814-9. doi: 10.1136/gut.2010.218305. Epub 2011 Jan 31.
Konvalina G, Haick H. Effect of humidity on nanoparticle-based chemiresistors: a comparison between synthetic and real-world samples. ACS Appl Mater Interfaces. 2012 Jan;4(1):317-25. doi: 10.1021/am2013695. Epub 2011 Dec 15.
Hagemann LT, Ehrle S, Mizaikoff B. Optimizing the Analytical Performance of Substrate-Integrated Hollow Waveguides: Experiment and Simulation. Appl Spectrosc. 2019 Dec;73(12):1451-1460. doi: 10.1177/0003702819867342. Epub 2019 Aug 22.
Hagemann LT , McCartney MM , Fung AG , Peirano DJ , Davis CE , Mizaikoff B . Portable combination of Fourier transform infrared spectroscopy and differential mobility spectrometry for advanced vapor phase analysis. Analyst. 2018 Nov 19;143(23):5683-5691. doi: 10.1039/c8an01192c.
Tutuncu E, Nagele M, Becker S, Fischer M, Koeth J, Wolf C, Kostler S, Ribitsch V, Teuber A, Groger M, Kress S, Wepler M, Wachter U, Vogt J, Radermacher P, Mizaikoff B. Advanced Photonic Sensors Based on Interband Cascade Lasers for Real-Time Mouse Breath Analysis. ACS Sens. 2018 Sep 28;3(9):1743-1749. doi: 10.1021/acssensors.8b00477. Epub 2018 Aug 20.
Glockler J, Jaeschke C, Kocaoz Y, Kokoric V, Tutuncu E, Mitrovics J, Mizaikoff B. iHWG-MOX: A Hybrid Breath Analysis System via the Combination of Substrate-Integrated Hollow Waveguide Infrared Spectroscopy with Metal Oxide Gas Sensors. ACS Sens. 2020 Apr 24;5(4):1033-1039. doi: 10.1021/acssensors.9b02554. Epub 2020 Mar 31.
Chandrapalan S, Arasaradnam RP. Urine as a biological modality for colorectal cancer detection. Expert Rev Mol Diagn. 2020 May;20(5):489-496. doi: 10.1080/14737159.2020.1738928. Epub 2020 Mar 11.
Gasenko E, Leja M, Polaka I, Hegmane A, Murillo R, Bordin D, Link A, Kulju M, Mochalski P, Shani G, Malfertheiner P, Herrero R, Haick H. How do international gastric cancer prevention guidelines influence clinical practice globally? Eur J Cancer Prev. 2020 Sep;29(5):400-407. doi: 10.1097/CEJ.0000000000000580.
Lawler M, Alsina D, Adams RA, Anderson AS, Brown G, Fearnhead NS, Fenwick SW, Halloran SP, Hochhauser D, Hull MA, Koelzer VH, McNair AGK, Monahan KJ, Nathke I, Norton C, Novelli MR, Steele RJC, Thomas AL, Wilde LM, Wilson RH, Tomlinson I; Bowel Cancer UK Critical Research Gaps in Colorectal Cancer Initiative. Critical research gaps and recommendations to inform research prioritisation for more effective prevention and improved outcomes in colorectal cancer. Gut. 2018 Jan;67(1):179-193. doi: 10.1136/gutjnl-2017-315333.
Broza YY, Mochalski P, Ruzsanyi V, Amann A, Haick H. Hybrid volatolomics and disease detection. Angew Chem Int Ed Engl. 2015 Sep 14;54(38):11036-48. doi: 10.1002/anie.201500153. Epub 2015 Jul 31.
Other Identifiers
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1.1.1.1/20/A/035
Identifier Type: -
Identifier Source: org_study_id
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