VOCs vs FIT for Colorectal Cancer Screening

The Effectiveness of Breath Analysis Versus FIT for Colorectal Cancer Screening

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Colorectal Polyp
• Intervention / Treatment: Procedure: 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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Dept of Emergency and Organ transplantation
    • Contact: Donato F Altomare, MD; Phone Number: 00390805478764; Email: altomare@clichiru.uniba.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Healthy subjects; The breath of all patients with positive FIT (fecal immunochemical test) but negative colonoscopy will be sampled using a breath sampler	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
ACTIVE_COMPARATOR: Colorectal Cancer patients; The breath of all patients with positive FIT (fecal immunochemical test) and a colorectal cancer detected by colonoscopy will be sampled using a breath sampler	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
ACTIVE_COMPARATOR: Colonic Polyps patients; The breath of all patients with positive FIT (fecal immunochemical test) and a colonic polyp detected by colonoscopy will be sampled using a breath sampler	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FIT sensitivity	Evaluate the sensitivity of fecal immunochemical test to detect Colorectal cancer patients	30 days
Breath analysis sensitivity	Evaluate the sensitivity Breath analysis to detect colorectal cancer patients	30 days

Collaborators and Investigators

• Sponsor: Societa Italiana di Chirurgia ColoRettale
• Investigators: Study Chair: Elisabetta Martinelli, MD, Societa Italiana di Chirurgia ColoRettale

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2020
• Primary Completion (ANTICIPATED): May 2, 2022
• Study Completion (ANTICIPATED): May 30, 2022

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (ACTUAL): May 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

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: 27/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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