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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Precancerous Condition; CRC

• Study Type: Observational
• Enrollment (Estimated): 453

Contacts and Locations

• Study Contact: Name: Mei Zhang; Phone Number: 13810021517; Email: meizhang@bucm.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing University of Chinese Medicine
      • Contact: Mei Zhang; Phone Number: +8613810021517; Email: meizhang@bucm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy Control
Colorectal Cancer
Precancerous Lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic accuracy of the odor-based test using volatile organic compounds (VOCs) for detecting colorectal cancer and precancerous lesions	Baseline

Collaborators and Investigators

• Sponsor: Beijing University of Chinese Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Precancerous Conditions
• Other Study ID Numbers: 2026BZYLL0303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No