Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2020-05-02
2022-05-30
Brief Summary
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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
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Healthy subjects
The breath of all patients with positive FIT (fecal immunochemical test) but negative colonoscopy will be sampled using a breath sampler
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
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
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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Patients included in the regional screening program for CRC
* Written informed consent
Exclusion Criteria
* Inflammatory bowel disease
* Bowel prep
* Any psychiatric disease
* Previous (or still present) cancers in other organs
35 Years
85 Years
ALL
No
Sponsors
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Societa Italiana di Chirurgia ColoRettale
NETWORK
Responsible Party
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Principal Investigators
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Elisabetta Martinelli, MD
Role: STUDY_CHAIR
Societa Italiana di Chirurgia ColoRettale
Locations
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Dept of Emergency and Organ transplantation
Bari, , Italy
Countries
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Central Contacts
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Facility Contacts
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Donato F Altomare, MD
Role: primary
References
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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.
Other Identifiers
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27/2020
Identifier Type: -
Identifier Source: org_study_id