Clinical trial · Observational
Hybrid-sensor Breath Analysis for Colorectal Cancer Screening
Hybrid-sensor Breath Analysis for Colorectal Cancer Screening (HYCOR)
NCT05173077CI-TRIAL-00056531HYCORunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this project is to promote the breath volatile marker concept for colorectal cancer (CRC) screening by advancing developing the application of a novel hybrid analyzer for the purpose. The hybrid analyzer concept is expected to benefit of combining metal-oxide (MOX) and infrared spectrum (IR) sensor acquired data. The current study will be the first globally to address this concept in CRC detection. In addition, traditional methods, in particular, gas chromatography coupled to mass spectrometry (GC-MS) will be used to address the biological relevance of the VOCs emission from cancer tissue and will assist in further advances of the hybrid-sensing approach.
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 |
| Polyp of Colon | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample collection | Other | — | UNRESOLVED |
| Breath sampling for VOC detection | Device | — | UNRESOLVED |
| Colonoscopy | Diagnostic Test | — | UNRESOLVED |
| Identification of specific VOCs in CRC tissue surgery material | Procedure | — | UNRESOLVED |
| Microbiota testing | Diagnostic Test | — | UNRESOLVED |
| Secondary validation study in general CRC screening settings | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Colorectal cancer patients
- description
- Patients with histologically confirmed colorectal cancer (adenocarcinoma)
- interventionNames
- Device: Breath sampling for VOC detection
- Other: Blood sample collection
- Diagnostic Test: Microbiota testing
- label
- Control group patients without colorectal cancer
- description
- Patients without colorectal malignant disease according to data obtained in colonoscopy
- interventionNames
- Device: Breath sampling for VOC detection
- Other: Blood sample collection
- Diagnostic Test: Microbiota testing
- Diagnostic Test: Colonoscopy
- label
- Average risk population
- description
- Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult individuals (\>18 years of age) * Having signed the consent form * Willingness to collaborate * Able to provide a breath sample * For the cancer group: colorectal adenocarcinoma has to be documented histologically (histological diagnosis following gastric surgery is also accepted) or patients being confirmed adenocarcinoma during the course of the study. * For the non-cancer group: control group - any patient who have medical indications for a colonoscopy Exclusion Criteria: * The patient has not signed the consent form * Patients who have had a complete bowel cleansing * Other active malignancies * Neoadjuvant chemotherapy, radiation therapy is currently underway * Acute conditions (emergency surgery for the patient) * Small bowel resection in the past * Terminal renal failure (Chronic renal failure stage 4) * Type I diabetes * Bronchial asthma (active)
References
Publications (14)
- RESULTArnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27. PMID 26818619
- RESULTJurs PC, Bakken GA, McClelland HE. Computational methods for the analysis of chemical sensor array data from volatile analytes. Chem Rev. 2000 Jul 12;100(7):2649-78. doi: 10.1021/cr9800964. No abstract available. PMID 11749299
- RESULTvan Keulen KE, Jansen ME, Schrauwen RWM, Kolkman JJ, Siersema PD. Volatile organic compounds in breath can serve as a non-invasive diagnostic biomarker for the detection of advanced adenomas and colorectal cancer. Aliment Pharmacol Ther. 2020 Feb;51(3):334-346. doi: 10.1111/apt.15622. Epub 2019 Dec 20. PMID 31858615
- RESULTZhou W, Tao J, Li J, Tao S. Volatile organic compounds analysis as a potential novel screening tool for colorectal cancer: A systematic review and meta-analysis. Medicine (Baltimore). 2020 Jul 2;99(27):e20937. doi: 10.1097/MD.0000000000020937. PMID 32629696
- RESULTSonoda H, Kohnoe S, Yamazato T, Satoh Y, Morizono G, Shikata K, Morita M, Watanabe A, Morita M, Kakeji Y, Inoue F, Maehara Y. Colorectal cancer screening with odour material by canine scent detection. Gut. 2011 Jun;60(6):814-9. doi: 10.1136/gut.2010.218305. Epub 2011 Jan 31. PMID 21282130
- RESULTKonvalina G, Haick H. Effect of humidity on nanoparticle-based chemiresistors: a comparison between synthetic and real-world samples. ACS Appl Mater Interfaces. 2012 Jan;4(1):317-25. doi: 10.1021/am2013695. Epub 2011 Dec 15. PMID 22121824
- RESULTHagemann LT, Ehrle S, Mizaikoff B. Optimizing the Analytical Performance of Substrate-Integrated Hollow Waveguides: Experiment and Simulation. Appl Spectrosc. 2019 Dec;73(12):1451-1460. doi: 10.1177/0003702819867342. Epub 2019 Aug 22.