An observational study in Colorectal Cancer and Colon Polyp, sponsored by Societa Italiana di Chirurgia ColoRettale. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-03.
Sponsored by Societa Italiana di Chirurgia ColoRettale · Observational
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.
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.
5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 90 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Societa Italiana di Chirurgia ColoRettale is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients which will be consulted at the Tertiary center of colorectal surgery (Policlinico of Bari)
Exclusion Criteria:
Patients with histologically proven Colorectal cancer detected during the colonoscopy
Diagnostic Test: Breath sampling
Patients with no sign of any colorectal disease who are submitted to colonoscopy
Diagnostic Test: Breath sampling
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
Test Sensitivity and specificity for colorectal cancer
A specificity of 80% and a sensitivity of 90% will be considered reliable
Time frame: 30 days
Test Sensitivity and specificity for colorectal polyps
A specificity of 80% and a sensitivity of 90% will be considered reliable
Time frame: 30 days
Plan to share: No
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Societa Italiana di Chirurgia ColoRettale