Clinical trial · Observational
Noninvasive Early Diagnosis of Colorectal Cancer Using Odor-Targeted Capture, Point-of-Care Testing, and Intelligent Analysis
Key Technology Research on Non-invasive Early Diagnosis of Colorectal Cancer Based on Odor-targeted Capture, Instant Detection, and Intelligent Analysis
- 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 goal of this observational study is to see whether a new, noninvasive test that analyzes smells (odor) from breath and intestinal gas can help detect colorectal cancer and precancerous growths at an early stage. The main questions it aims to answer are: Can the new odor-based test correctly identify people who have colorectal cancer or precancerous lesions? How accurate is the new test compared to the current standard method (colonoscopy with biopsy)? Researchers will compare the results of the new test with standard diagnostic results. Participants will be asked to: Provide samples of breath, urine, stool, and intestinal gas (collected using a special device or a collection bag) Allow researchers to review their medical records and colonoscopy results Answer questions about their health history and lifestyle This study involves no treatments or procedures beyond normal medical care. It only collects samples and data for research purposes.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CRC | Colorectal Carcinoma | ALIAS | 0.90 |
| Healthy | — | UNRESOLVED | — |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Colorectal Cancer
- label
- Precancerous Lesion
- label
- Healthy Control
Primary outcomes (1)
- measure
- Diagnostic accuracy of the odor-based test using volatile organic compounds (VOCs) for detecting colorectal cancer and precancerous lesions
- timeFrame
- Baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 to 85 years, male or female * Histopathologically or cytologically confirmed colon or rectal cancer (TNM stage I-IV) for colorectal cancer group * Histopathologically confirmed adenomatous polyps, sessile serrated lesions, traditional serrated adenomas, or other precancerous lesions for precancerous lesion group * No abnormality on colonoscopy within the past year; no personal history of colorectal cancer or other malignancies; no chronic diseases requiring long-term treatment for healthy control group * Willing and able to provide signed informed consent Exclusion Criteria: * Hereditary colorectal cancer syndromes (e.g., familial adenomatous polyposis, hereditary non-polyposis colorectal cancer) * Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis) * Severe cardiovascular, respiratory, or urinary system diseases * Other primary malignant tumors * Hematological diseases * Unable to comply with study procedures (e.g., sample collection or questionnaires) * Planning to become pregnant, pregnant, or breastfeeding * Suspected or confirmed alcohol or drug abuse * Known allergy to any drug used for colorectal cancer treatment * Participation in another interventional drug clinical trial within the past month * Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study
References
Publications (3)
- RESULTLi Z, Li Y, Zhan L, Meng L, Huang X, Wang T, Li Y, Nie Z. Point-of-Care Test Paper for Exhaled Breath Aldehyde Analysis via Mass Spectrometry. Anal Chem. 2021 Jul 6;93(26):9158-9165. doi: 10.1021/acs.analchem.1c01011. Epub 2021 Jun 24. PMID 34162204
- RESULTHanevelt J, Schoenaker IJH, Brohet RM, Schrauwen RWM, Baas FJN, Tanis PJ, van Westreenen HL, de Vos Tot Nederveen Cappel WH. Alteration of the Exhaled Volatile Organic Compound Pattern in Colorectal Cancer Patients after Intentional Curative Surgery-A Prospective Pilot Study. Cancers (Basel). 2023 Sep 29;15(19):4785. doi: 10.3390/cancers15194785. PMID 37835479
- RESULTChung J, Akter S, Han S, Shin Y, Choi TG, Kang I, Kim SS. Diagnosis by Volatile Organic Compounds in Exhaled Breath in Exhaled Breath from Patients with Gastric and Colorectal Cancers. Int J Mol Sci. 2022 Dec 21;24(1):129. doi: 10.3390/ijms24010129. PMID 36613569