CRCNCT07620743
Noninvasive Early Diagnosis of Colorectal Cancer Using Odor-Targeted Capture, Point-of-Care Testing, and Intelligent Analysis
An observational study of CRC and Precancerous Condition, run by Beijing University of Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- CRC, Precancerous Condition, Healthy
- How many people
- 453 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing University of Chinese Medicine
Beijing, Beijing Municipality
Mei Zhang, +8613810021517, meizhang@bucm.edu.cn
About this study
Official title: 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:
Read more
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
- Medical subject headings
- Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer | Not described | |
| Precancerous Lesion | Not described | |
| Healthy Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the odor-based test using volatile organic compounds (VOCs) for detecting colorectal cancer and precancerous lesions
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CRCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 453 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Zhang, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620743
- Sponsor's protocol ID
- 2026BZYLL0303
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 34162204Hanevelt 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 37835479Chung 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key Technology Research on Non-invasive Early Diagnosis of Colorectal Cancer Based on Odor-targeted Capture, Instant Detection, and Intelligent Analysis
- ClinicalTrials.gov ID
- NCT07620743
- Acronym / sponsor ID
- 2026BZYLL0303
- Conditions
- CRC, Precancerous Condition, Healthy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 453 participants (estimated)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer | – | – |
| Precancerous Lesion | – | – |
| Healthy Control | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of the odor-based test using volatile organic compounds (VOCs) for detecting colorectal cancer and precancerous lesions
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Results publication: PubMed 34162204Li 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.
- Results publication: PubMed 37835479Hanevelt 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.
- Results publication: PubMed 36613569Chung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CRC and Precancerous Condition, run by Beijing University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei Zhang (13810021517, meizhang@bucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the odor-based test using volatile organic compounds (VOCs) for detecting colorectal cancer and precancerous lesions (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07620743, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.