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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorectal Cancer | |||
| Precancerous Lesion | |||
| Healthy Control |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of the odor-based test using volatile organic compounds (VOCs) for detecting colorectal cancer and precancerous lesions | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of three groups recruited primarily from Beijing University of Chinese Medicine, Dongfang Hospital:
Patients with histopathologically confirmed colorectal cancer (TNM stage I-IV).
Patients with histopathologically confirmed precancerous lesions (e.g., colorectal adenomas, sessile serrated lesions).
Healthy controls with no abnormalities on colonoscopy within the past year and no history of colorectal cancer or other malignancies.
Participants will be adults aged 18 to 85 years. Healthy controls will be recruited from the same hospital settings and matched for key demographic factors (age, sex, BMI) and lifestyle habits to minimize confounding.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Zhang | Contact | 13810021517 | meizhang@bucm.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing University of Chinese Medicine | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34162204 | Result | Li 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. | |
| 37835479 | Result | Hanevelt 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. |
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| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 36613569 | Result | Chung 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. |