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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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04217083
Enrollment
90
Registered
2020-01-03
Start date
2019-01-02
Completion date
2021-01-20
Last updated
2020-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Colon Polyp

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTBreath 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

Sponsors

Societa Italiana di Chirurgia ColoRettale
Lead SponsorNETWORK

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Test Sensitivity and specificity for colorectal cancer30 daysA specificity of 80% and a sensitivity of 90% will be considered reliable

Secondary

MeasureTime frameDescription
Test Sensitivity and specificity for colorectal polyps30 daysA specificity of 80% and a sensitivity of 90% will be considered reliable

Countries

Italy

Contacts

Primary ContactDonato Altomare, Prof
donatofrancesco.altomare@uniba.it+393397593066
Backup ContactArcangelo Picciariello, MD
arcangelopicciariello@gmail.com+393492185104

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026