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NCT07620743Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 2 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
453 (estimated)
First submitted
25 May 2026
Start date
10 Jun 2026
Primary completion date
31 Dec 2029
Lead sponsor
Beijing University of Chinese Medicine
NCT number
NCT07620743

What you commit to

  • Study type: Observational
  • Planned participants: 453
  • From 10 Jun 2026 to the primary completion date, 31 Dec 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Suspected or confirmed alcohol or drug abuse
  • Participation in another interventional drug clinical trial within the past month

Other illness

  • 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
  • Known allergy to any drug used for colorectal cancer treatment
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study

Other

  • Unable to comply with study procedures (e.g., sample collection or questionnaires)
  • Planning to become pregnant, pregnant, or breastfeeding

Who the study is looking for

  • 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

Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing University of Chinese Medicine
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.