VOCs vs FIT for Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

Official title:

The Effectiveness of Breath Analysis Versus FIT for Colorectal Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04407416
• Other study ID #: 27/2020
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: May 2020
• Source: Societa Italiana di Chirurgia ColoRettale
• Contact: Donato Altomare, Prof
• Phone: +393397593066
• Email: donatofrancesco.altomare[@]uniba.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endogenous breath VOCs (Volatile Organic Compounds) are present in various excreted biological materials (urine, blood, faeces an breath) and their analysis offers a possibility for cancer screening. Some of these VOCs are reversed in the venous blood stream and reach the lung alveoli where some of them are exhaled.

Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of cancer-related mortality. Colonoscopy is the gold standard for the diagnosis of CRC.

Screening with fecal immunochemical test (FIT) is associated with a 13-18% CRC-mortality reduction.

Aim of the study To compare the reliability of this breath analysis with Immunochemically-based Fecal Occult Blood Test.

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 are present in various excreted biological materials (urine, blood, faeces an breath) and their analysis offers a possibility for cancer screening. Some of these VOCs are reversed in the venous blood stream and reach the lung alveoli where some of them are exhaled.

Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of cancer-related mortality. 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. Screening with fecal immunochemical test (FIT) is associated with a 13-18% CRC-mortality reduction in major randomized studies and is the most widely used non-invasive 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.

Recently the breath analysis has been demonstrated to be a new well accepted and non-invasive tool to detect colorectal cancer.

The purpose of this trial is to compare the reliability of this breath analysis with Immunochemically-based Fecal Occult Blood Test, which is the routinely employed tool for mass screening. A group of subjects adherent to the regional screening program for colorectal cancer prevention, who resulted positive to the FIT, will be enrolled in this study, and will have a breath sampling before undergoing colonoscopy. The predictive ability of the Breath test will be tested in a blind fashion in this selected group of high-risk subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 30, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with and without positive FIT with a planned colonoscopy

• Patients included in the regional screening program for CRC

• Written informed consent

Exclusion Criteria:

• Pregnancy

• Inflammatory bowel disease

• Bowel prep

• Any psychiatric disease

• Previous (or still present) cancers in other organs

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Polyp

Intervention

Procedure:
• Breath sampling
The breath of all subjects included will be sampled using a device able to capture the alveolar air and to fix it on carbon tubes, Then the tubes will be desorbed and analysed using gas chromatography

Locations

Country	Name	City	State
Italy	Dept of Emergency and Organ transplantation	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

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

Mousavinezhad M, Majdzadeh R, Akbari Sari A, Delavari A, Mohtasham F. The effectiveness of FOBT vs. FIT: A meta-analysis on colorectal cancer screening test. Med J Islam Repub Iran. 2016 May 9;30:366. eCollection 2016. — View Citation

Stracci F, Zorzi M, Grazzini G. Colorectal cancer screening: tests, strategies, and perspectives. Front Public Health. 2014 Oct 27;2:210. doi: 10.3389/fpubh.2014.00210. eCollection 2014. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FIT sensitivity	Evaluate the sensitivity of fecal immunochemical test to detect Colorectal cancer patients	30 days
Primary	Breath analysis sensitivity	Evaluate the sensitivity Breath analysis to detect colorectal cancer patients	30 days