Clinical trial · Observational
Volatile Markers in Digestive Cancer
Volatile Marker Testing for Digestive Cancer and Precancerous Lesion Detection, Evaluation of Confounding Factors
NCT02332213CI-TRIAL-00034480VOLGACOREcompletedClinicalTrials.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 study is aimed to determine the potential of volatile marker testing for identification of gastrointestinal cancers (in particular - colorectal and gastric cancers), the related precancerous lesions in the stomach and colon. The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrophic Gastritis | — | UNRESOLVED | — |
| Average-risk General Population | — | UNRESOLVED | — |
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| H.Pylori Infection | — | UNRESOLVED | — |
| Intestinal Metaplasia | — | UNRESOLVED | — |
| Normal Control | — | UNRESOLVED | — |
| Peptic Ulcer Disease | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breath sampling for volatile marker detection | Procedure | — | UNRESOLVED |
| Colonoscopy with biopsies or lesion removal when required | Procedure | — | UNRESOLVED |
| Faecal sample acquisition | Procedure | — | UNRESOLVED |
| Histological evaluation of the surgery material | Procedure | — | UNRESOLVED |
| Plasma/serum sampling | Procedure | — | UNRESOLVED |
| Upper endoscopy with biopsies | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- label
- 1. Colorectal cancer
- description
- Patients with histologically confirmed colorectal cancer (adenocarcinoma)
- interventionNames
- Procedure: Breath sampling for volatile marker detection
- Procedure: Colonoscopy with biopsies or lesion removal when required
- Procedure: Plasma/serum sampling
- Procedure: Faecal sample acquisition
- Procedure: Histological evaluation of the surgery material
- label
- 2. Colorectal high-risk lesions
- description
- Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions.
- interventionNames
- Procedure: Breath sampling for volatile marker detection
- Procedure: Colonoscopy with biopsies or lesion removal when required
- Procedure: Plasma/serum sampling
- Procedure: Faecal sample acquisition
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with verifies colorectal cancer (Group 1) * Patients with verified gastric cancer (Group 5) * Patients undergoing colonoscopy due to clinical indications (group 2-4) * Patients undergoing upper endoscopy due to clinical indications (Group 6-8) * Average-risk population group aged 40-64 at inclusion without alarm symptoms (Group 9) * Motivation to participate in the study * Physical status allowing volatile marker sampling and other procedures within the protocol * Signed consent Exclusion Criteria: * Known other active cancer * Ventilation problems, airway obstruction * Unwillingness or inability to co-operate
References
Publications (3)
- BACKGROUNDHaick H, Broza YY, Mochalski P, Ruzsanyi V, Amann A. Assessment, origin, and implementation of breath volatile cancer markers. Chem Soc Rev. 2014 Mar 7;43(5):1423-49. doi: 10.1039/c3cs60329f. Epub 2013 Dec 4. PMID 24305596
- BACKGROUNDXu ZQ, Broza YY, Ionsecu R, Tisch U, Ding L, Liu H, Song Q, Pan YY, Xiong FX, Gu KS, Sun GP, Chen ZD, Leja M, Haick H. A nanomaterial-based breath test for distinguishing gastric cancer from benign gastric conditions. Br J Cancer. 2013 Mar 5;108(4):941-50. doi: 10.1038/bjc.2013.44. PMID 23462808
- BACKGROUNDAmal H, Leja M, Broza YY, Tisch U, Funka K, Liepniece-Karele I, Skapars R, Xu ZQ, Liu H, Haick H. Geographical variation in the exhaled volatile organic compounds. J Breath Res. 2013 Dec;7(4):047102. doi: 10.1088/1752-7155/7/4/047102. Epub 2013 Nov 1. PMID 24184568