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: Unknown
• Conditions: Colorectal Cancer; Colon Polyp
• Intervention / Treatment: Diagnostic test: Breath sampling

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: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Dept of Emergency and Organ transplantation - University of Bari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients which will be consulted at the Tertiary center of colorectal surgery (Policlinico of Bari)

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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Colorectal cancer patients; Patients with histologically proven Colorectal cancer detected during the 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
healthy controls; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test Sensitivity and specificity for colorectal cancer	A specificity of 80% and a sensitivity of 90% will be considered reliable	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test Sensitivity and specificity for colorectal polyps	A specificity of 80% and a sensitivity of 90% will be considered reliable	30 days

Collaborators and Investigators

• Sponsor: Societa Italiana di Chirurgia ColoRettale
• 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): January 2, 2019
• Primary Completion (Anticipated): December 25, 2020
• Study Completion (Anticipated): January 20, 2021

Study Registration Dates

• First Submitted: December 29, 2019
• First Submitted That Met QC Criteria: December 31, 2019
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: December 31, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 141/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No