ClinicalTrials.gg
Not yet recruitingNCT07620743Updated Jun 2, 2026

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

An observational study in CRC, Precancerous Condition and Healthy, sponsored by Beijing University of Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by Beijing University of Chinese Medicine · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
453
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • CRC
  • Precancerous Condition
  • Healthy
03

In context

Precancerous Conditions

217 studies on the registry are indexed under Precancerous Conditions; 16 are open to participants now.

This study's planned enrollment of 453 is above the median of 365 across 45 observational studies indexed under Precancerous Conditions.

Browse Precancerous Conditions studies →

Lead sponsor

Beijing University of Chinese Medicine is the lead sponsor of 32 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 to 85 years, male or female
  • Histopathologically or 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 ; no chronic diseases requiring long-term treatment for healthy control group
  • Willing and able to provide signed

Exclusion criteria

Exclusion Criteria:

  • Hereditary colorectal cancer syndromes (e.g., familial adenomatous polyposis, hereditary non-polyposis colorectal cancer)
  • 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
453 participants (estimated)
Patient registry
No

Groups and cohorts

  • Colorectal Cancer
  • Precancerous Lesion
  • Healthy Control
06

What researchers measure

Primary outcomes

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

    Time frame: Baseline

07

Study locations

1 site
  • Beijing University of Chinese Medicine
    Beijing, Beijing Municipality, China
08

References and documents

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. PubMed 34162204 ↗
  • 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. PubMed 37835479 ↗
  • 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. PubMed 36613569 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2026; primary completion for Dec 2029, 42 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2026
First posted
Jun 2, 2026
StartEst.
Jun 10, 2026
Primary completionEst.
Dec 31, 2029
CompletionEst.
Dec 31, 2029
Last update
Jun 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07620743
Lead sponsor
Beijing University of Chinese Medicine
Responsible party
Mei Zhang (Research Professor, Beijing University of Chinese Medicine) — Principal investigator
First posted
Jun 2, 2026
Start date
Jun 10, 2026 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jun 2, 2026

Study contacts

Mei Zhang
Contact
meizhang@bucm.edu.cn
13810021517

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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