Volatile Organic Compounds (VOCs) Profile in Colorectal Cancer Patients and Healthy Controls.
Volatile Organic Compounds (VOCs) Could Discriminate Patients With Colorectal Cancer From Healthy Controls.
Volatile organic compounds (VOCs) are low molecular weight (<1 kDa) compounds which represent the final products of cell metabolism. Their composition can be affected by several factors including diet, hormones, environment and the presence of diseases, in particular, cancer.
Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of cancer-related mortality.
The expression of VOCs in breath that are linked to a patient's disease state could offers a powerful, non-invasive approach to identifying CRC patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Volatile organic compounds (VOCs) are low molecular weight (<1 kDa) compounds which represent the final products of cell metabolism. Their composition can be affected by several factors including diet, hormones, environment and the presence of diseases, in particular, cancer.
Endogenous breath VOCs can originate anywhere in the body, reversed in the venous blood stream and than to the lung alveoli where some of them are exhaled .
Alteration in VOC production in patients with cancer has been postulated to relate to (per)oxygenation of cell membrane-based polyunsaturated fatty acids resulting from genetic and/or protein mutations within tumour cells and the increased relative prevalence of reactive oxygen species within cancer cells. VOCs consist largely of benzene, alkanes and aldehydes (or their derivatives), and several studies have demonstrated that various cancers, including lung and breast cancer,melanoma, mesothelioma and hepatocellular carcinoma, are associated with specific VOC profiles that differ from normal.
Volatile organic compounds are present in various excreted biological materials (urine, blood, faeces an breath) and their analysis offers a possibility for cancer screening.
Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of cancer-related mortality. It is the second leading cause of cancer-related death in Europe and the third in the USA.
Colonoscopy is the gold standard for the diagnosis of CRC, although its cost prevents its use for mass screening. Furthermore colonoscopy is not well accepted by patients since it is an invasive exam. Faecal immunochemical blood testing (FIT) is the most widely used noninvasive screening tool, showing fairly good specificity but a high variation in sensitivity (61-91%) and adherence to screening programmes rarely reaches 50-70% of the target population.
The expression of VOCs in breath that are linked to a patient's disease state could offers a powerful, non-invasive approach to identifying CRC patients.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Bari, Italy, 70124
- Recruiting
- Dept of Emergency and Organ transplantation - University of Bari
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 18 and 95
- Histologically proven colorectal cancer
- Patient with single or multiple polyps of the colon
- Healthy subjects with negative colonoscopy
- Patients already sampled and operated for colorectal cancer with no sign of recurrence
- Written informed consent
Exclusion Criteria:
- Pregnancy
- Inflammatory bowel disease
- Synchronous cancers
- Liver and/or lung metastasis
- Bowel prep
- Recurrent CRC
- Any psychiatric disease
- Emergency operations
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Colorectal cancer patients
Patients with histologically proven Colorectal cancer detected during the colonoscopy
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The alveolar fraction of Colorectal cancer patients and Healthy controls will be sampled using a breath sampler able to fix the volatile organic compound on absorbable tubes
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healthy controls
Patients with no sign of any colorectal disease who are submitted to colonoscopy
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The alveolar fraction of Colorectal cancer patients and Healthy controls will be sampled using a breath sampler able to fix the volatile organic compound on absorbable tubes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Test Sensitivity and specificity for colorectal cancer
Time Frame: 30 days
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A specificity of 80% and a sensitivity of 90% will be considered reliable
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Test Sensitivity and specificity for colorectal polyps
Time Frame: 30 days
|
A specificity of 80% and a sensitivity of 90% will be considered reliable
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30 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Donato Altomare, Prof, Societa Italiana di Chirurgia ColoRettale
Publications and helpful links
General Publications
- Fuchs P, Loeseken C, Schubert JK, Miekisch W. Breath gas aldehydes as biomarkers of lung cancer. Int J Cancer. 2010 Jun 1;126(11):2663-70. doi: 10.1002/ijc.24970.
- Bond A, Greenwood R, Lewis S, Corfe B, Sarkar S, O'Toole P, Rooney P, Burkitt M, Hold G, Probert C. Volatile organic compounds emitted from faeces as a biomarker for colorectal cancer. Aliment Pharmacol Ther. 2019 Apr;49(8):1005-1012. doi: 10.1111/apt.15140. Epub 2019 Mar 3.
- Arasaradnam RP, McFarlane MJ, Ryan-Fisher C, Westenbrink E, Hodges P, Thomas MG, Chambers S, O'Connell N, Bailey C, Harmston C, Nwokolo CU, Bardhan KD, Covington JA. Detection of colorectal cancer (CRC) by urinary volatile organic compound analysis. PLoS One. 2014 Sep 30;9(9):e108750. doi: 10.1371/journal.pone.0108750. eCollection 2014. Erratum In: PLoS One. 2015;10(3):e0118975. Hodges, Paula [corrected to Hodges, Phoebe].
- Altomare DF, Di Lena M, Porcelli F, Trizio L, Travaglio E, Tutino M, Dragonieri S, Memeo V, de Gennaro G. Exhaled volatile organic compounds identify patients with colorectal cancer. Br J Surg. 2013 Jan;100(1):144-50. doi: 10.1002/bjs.8942.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 141/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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