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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Mei Zhang
- Telefonnummer: 13810021517
- E-post: meizhang@bucm.edu.cn
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina
- Beijing University of Chinese Medicine
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Ta kontakt med:
- Mei Zhang
- Telefonnummer: +8613810021517
- E-post: meizhang@bucm.edu.cn
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Sunn kontroll
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Tykktarmskreft
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Precancerous Lesion
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Diagnostic accuracy of the odor-based test using volatile organic compounds (VOCs) for detecting colorectal cancer and precancerous lesions
Tidsramme: Baseline
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Baseline
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026BZYLL0303
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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