Noninvasive Early Diagnosis of Colorectal Cancer Using Odor-Targeted Capture, Point-of-Care Testing, and Intelligent Analysis

NCT07620743 | Not Yet Recruiting

• 1 other identifier: 2026BZYLL0303
• Study Type: observational
• Target: 453
• Locations: 1 country
• Sites: 1

Brief Summary

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

CRC; Precancerous Condition; Healthy

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the odor-based test using volatile organic compounds (VOCs) for detecting colorectal cancer and precancerous lesions

  Baseline

Study Arms (3)

Colorectal Cancer

Precancerous Lesion

Healthy Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead

Study Sites (1)

Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Location

Related Publications (3)

• 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.

  PMID: 34162204 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.

  PMID: 37835479 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.

  PMID: 36613569 RESULT

MeSH Terms

Conditions

Precancerous Conditions

Condition Hierarchy (Ancestors)

Neoplasms

Central Study Contacts

Mei Zhang

CONTACT

13810021517; meizhang@bucm.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 2, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)