Not Yet RecruitingNot Applicable

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

China453 participantsStarted 2026-06-10

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline

Trial details

NCT IDNCT07620743

SponsorBeijing University of Chinese Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-12-31

Contact for this trial

Mei Zhang

13810021517 meizhang@bucm.edu.cn

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