Clinical trial · Interventional
VOCs vs FIT for Colorectal Cancer Screening
The Effectiveness of Breath Analysis Versus FIT for Colorectal Cancer Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Polyp | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breath sampling | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Healthy subjects
- description
- The breath of all patients with positive FIT (fecal immunochemical test) but negative colonoscopy will be sampled using a breath sampler
- interventionNames
- Procedure: Breath sampling
- type
- ACTIVE_COMPARATOR
- label
- Colorectal Cancer patients
- description
- 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
- interventionNames
- Procedure: Breath sampling
- type
- ACTIVE_COMPARATOR
- label
- Colonic Polyps patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (4)
- RESULTBond 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. PMID 30828825
- RESULTAltomare 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. PMID 23212621
- RESULTStracci 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. PMID 25386553
- RESULTMousavinezhad 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. PMID 27493910