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

Colorectal Cancer Clinical Trial

Official title:

Volatile Organic Compounds (VOCs) Could Discriminate Patients With Colorectal Cancer From Healthy Controls.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04217083
• Other study ID #: 141/2019
• Status: Recruiting
• Start date: January 2, 2019
• Est. completion date: January 20, 2021

Study information

• Verified date: December 2019
• Source: Societa Italiana di Chirurgia ColoRettale
• Contact: Donato Altomare, Prof
• Phone: +393397593066
• Email: donatofrancesco.altomare[@]uniba.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 20, 2021
• Est. primary completion date: December 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Polyp
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Dept of Emergency and Organ transplantation - University of Bari	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Societa Italiana di Chirurgia ColoRettale

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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 — View Citation

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.151 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test Sensitivity and specificity for colorectal cancer	A specificity of 80% and a sensitivity of 90% will be considered reliable	30 days
Secondary	Test Sensitivity and specificity for colorectal polyps	A specificity of 80% and a sensitivity of 90% will be considered reliable	30 days