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
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mei Zhang
- Número de teléfono: 13810021517
- Correo electrónico: meizhang@bucm.edu.cn
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana
- Beijing University of Chinese Medicine
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Contacto:
- Mei Zhang
- Número de teléfono: +8613810021517
- Correo electrónico: meizhang@bucm.edu.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Control saludable
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Cáncer colonrectal
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Precancerous Lesion
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Diagnostic accuracy of the odor-based test using volatile organic compounds (VOCs) for detecting colorectal cancer and precancerous lesions
Periodo de tiempo: Baseline
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Baseline
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026BZYLL0303
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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