VOCs vs FIT for Colorectal Cancer Screening

Not Applicable

• Conditions: Colorectal Polyp; Colorectal Cancer
• Interventions: Procedure: Breath sampling

• Registration Number: NCT04407416
• Lead Sponsor: Societa Italiana di Chirurgia ColoRettale

Brief 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.

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 Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-02
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-27
• Last Update Submitted: 2020-05-27
• Study First Posted: 2020-05-29
• Last Update Posted: 2020-05-29
• Primary Completion: 2022-05-02
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colorectal Cancer patients	Breath sampling	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
Healthy subjects	Breath sampling	The breath of all patients with positive FIT (fecal immunochemical test) but negative colonoscopy will be sampled using a breath sampler
Colonic Polyps patients	Breath sampling	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

Primary Outcome Measures

Name	Time	Method
FIT sensitivity	30 days	Evaluate the sensitivity of fecal immunochemical test to detect Colorectal cancer patients
Breath analysis sensitivity	30 days	Evaluate the sensitivity Breath analysis to detect colorectal cancer patients

Trial Locations

Locations (1)

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