Volatile Organic Compounds (VOCs) Profile in Colorectal Cancer Patients and Healthy Controls.

• Conditions: Colon Polyp; Colorectal Cancer
• Interventions: Diagnostic Test: Breath sampling

• Registration Number: NCT04217083
• Lead Sponsor: Societa Italiana di Chirurgia ColoRettale

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.

Study Timeline

• Study Start: 2019-01-02
• Status Verified: 2019-12
• Study First Submitted: 2019-12-29
• Study First Submitted QC: 2019-12-31
• Last Update Submitted: 2019-12-31
• Study First Posted: 2020-01-03
• Last Update Posted: 2020-01-03
• Primary Completion: 2020-12-25
• Study Completion: 2021-01-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy controls	Breath sampling	Patients with no sign of any colorectal disease who are submitted to colonoscopy
Colorectal cancer patients	Breath sampling	Patients with histologically proven Colorectal cancer detected during the colonoscopy

Primary Outcome Measures

Name	Time	Method
Test Sensitivity and specificity for colorectal cancer	30 days	A specificity of 80% and a sensitivity of 90% will be considered reliable

Secondary Outcome Measures

Name	Time	Method
Test Sensitivity and specificity for colorectal polyps	30 days	A specificity of 80% and a sensitivity of 90% will be considered reliable

Trial Locations

Locations (1)

Dept of Emergency and Organ transplantation - University of Bari; 🇮🇹 Bari, Italy