Pulmonary NodulesNCT06056999
New Method to Differentiate Benign and Malignant Pulmonary Nodules.
An observational study of Pulmonary Nodules, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The goal of this observational clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by peripheral blood detection in patients with pulmonary nodules (<3cm). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodules
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2023to Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pulmonary nodule <3cm who are admitted to China-Japan Friendship Hospital and are scheduled for puncture biopsy or surgery.
Who may be able to join
- Age ≥18 years;
- CT imaging shows the presence of pulmonary nodule <3cm which is scheduled for puncture biopsy or surgery (i.e., the target lesion), the presence of ≥2 target lesions of the same type (categorized by density) are allowed;
- Subjects are in good condition with Eastern Cooperative Oncology Group (ECOG) scale of 0-2;
- Subjects with fair vital organ function, defined as: white blood cells ≥3.0×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥90g/L, alanine aminotransferase and aspartate aminotransferase ≤2.5 times the upper limit of normal values, and serum creatinine <178μmol/L;
- Subjects must have the ability to understand and sign the informed consent in writing voluntarily.
Who cannot join
- Imaging examination have suggested the possibility of metastasis at other sites;
- ≥2 target lesions with different type categorized by density;
- History of malignant disease;
- Severe vascular lesions within the last 3 months, or known significant active infection, during acute/chronic tuberculosis infection, or severe cardiovascular and cerebrovascular diseases, dysfunction of liver and renal, or significant endocrine and metabolic disorders, or other serious concomitant diseases that are not controlled;
- The specialist/surgeon assessed that puncture or surgery is not available, with contraindication such as coagulation disorders, cardiorespiratory insufficiency, etc.;
- History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders, that may affect the signing of informed consent;
- Pregnant or breastfeeding women;
- Other conditions deemed by the investigator to be unsuitable for enrollment.
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, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Guangying Zhu, +86-1084205381, zryyfa@163.com
About this study
Official title: A New Method to Differentiate Benign and Malignant Pulmonary Nodules by Mass Spectrometry Combined With Artificial Intelligence.
The goal of this observational clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by peripheral blood detection in patients with pulmonary nodules (<3cm). The main questions it aims to answer is: How to combine blood metabolomic mass spectrometry detection and artificial intelligence image analysis to establish a new model for differentiating benign and malignant pulmonary nodules. Participants will be asked provide 4 mL peripheral blood for the test.
Read the detailed description
The aim of this clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by the combination of metabolomics analysis and artificial intelligence (AI) analysis. It is expected to improve the accuracy of the identification of benign and malignant pulmonary nodules. Patients with clinical suspected malignant pulmonary nodules will be included in this trial. The subjects will be divided into three group by CT image presentation: (1) pure ground-glass nodule (pGGN), (2) part-solid nodule (PSN), (3) solid nodule (SN). Peripheral blood of subjects will be collected and detected by mass spectrometry to obtain the metabolomic characterization. The classification model of each group will be constructed based on the data analysis algorithm by machine learning. The diagnostic efficacy of the new model combined with the AI image analysis system for differentiating benign and malignant pulmonary nodules will be analyzed.
- Conditions
- Pulmonary Nodules
- Keywords
- differential diagnosis, benign and malignant pulmonary nodules, early diagnosis of lung cancer
- Medical subject headings
- Multiple Pulmonary Nodules
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 |
|---|---|---|
| A. pure ground-glass nodule | Patients with pure ground-glass nodules (GGNs). | |
| B. part-solid nodule | Patients with part-solid nodules (PSNs). | |
| C. solid nodule | Patients with solid nodules (SNs). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish an model for differentiating lung nodules.
To establish a new method for differentiating benign and malignant pulmonary nodules by the combination of metabolomics analysis and artificial intelligence (AI) image analysis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start29 Sep 2023
- Primary completionJan 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NodulesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangying Zhu, China-Japan Friendship Hospital
- Investigators
- Guangying Zhu, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056999
- Sponsor's protocol ID
- 2023-KY-0277
- Other IDs
- 2023-NHLHCRF-YYPPLC-ZR-02
- Status last verified
- Dec 2024
- First submitted
- 21 Sep 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Original research data including study protocol and statistical analysis plan will be shared after the study is completed and the research results are published.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method to Differentiate Benign and Malignant Pulmonary Nodules by Mass Spectrometry Combined With Artificial Intelligence.
- ClinicalTrials.gov ID
- NCT06056999
- Acronym / sponsor ID
- 2023-KY-0277
- Conditions
- Pulmonary Nodules
- Keywords
- differential diagnosis, benign and malignant pulmonary nodules, early diagnosis of lung cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 28 Sep 2023 (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 clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by peripheral blood detection in patients with pulmonary nodules (<3cm). The main questions it aims to answer is: How to combine blood metabolomic mass spectrometry detection and artificial intelligence image analysis to establish a new model for differentiating benign and malignant pulmonary nodules. Participants will be asked provide 4 mL peripheral blood for the test.
Detailed description
The aim of this clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by the combination of metabolomics analysis and artificial intelligence (AI) analysis. It is expected to improve the accuracy of the identification of benign and malignant pulmonary nodules. Patients with clinical suspected malignant pulmonary nodules will be included in this trial. The subjects will be divided into three group by CT image presentation: (1) pure ground-glass nodule (pGGN), (2) part-solid nodule (PSN), (3) solid nodule (SN). Peripheral blood of subjects will be collected and detected by mass spectrometry to obtain the metabolomic characterization. The classification model of each group will be constructed based on the data analysis algorithm by machine learning. The diagnostic efficacy of the new model combined with the AI image analysis system for differentiating benign and malignant pulmonary nodules will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A. pure ground-glass nodule | – | –Patients with pure ground-glass nodules (GGNs). |
| B. part-solid nodule | – | –Patients with part-solid nodules (PSNs). |
| C. solid nodule | – | –Patients with solid nodules (SNs). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary nodule <3cm who are admitted to China-Japan Friendship Hospital and are scheduled for puncture biopsy or surgery.
Key inclusion criteria (5 listed)
- Age ≥18 years;
- CT imaging shows the presence of pulmonary nodule <3cm which is scheduled for puncture biopsy or surgery (i.e., the target lesion), the presence of ≥2 target lesions of the same type (categorized by density) are allowed;
- Subjects are in good condition with Eastern Cooperative Oncology Group (ECOG) scale of 0-2;
- Subjects with fair vital organ function, defined as: white blood cells ≥3.0×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥90g/L, alanine aminotransferase and aspartate aminotransferase ≤2.5 times the upper limit of normal values, and serum creatinine <178μmol/L;
- Subjects must have the ability to understand and sign the informed consent in writing voluntarily.
Key exclusion criteria (8 listed)
- Imaging examination have suggested the possibility of metastasis at other sites;
- ≥2 target lesions with different type categorized by density;
- History of malignant disease;
- Severe vascular lesions within the last 3 months, or known significant active infection, during acute/chronic tuberculosis infection, or severe cardiovascular and cerebrovascular diseases, dysfunction of liver and renal, or significant endocrine and metabolic disorders, or other serious concomitant diseases that are not controlled;
- The specialist/surgeon assessed that puncture or surgery is not available, with contraindication such as coagulation disorders, cardiorespiratory insufficiency, etc.;
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
Establish an model for differentiating lung nodules.
Time frame: 6 months
To establish a new method for differentiating benign and malignant pulmonary nodules by the combination of metabolomics analysis and artificial intelligence (AI) image analysis.
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 18 Dec 2024.
- Individual participant dataSharing planned: Yes. Original research data including study protocol and statistical analysis plan will be shared after the study is completed and the research results are published.
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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.
Guangying Zhu principal investigator
China-Japan Friendship Hospital
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 Pulmonary Nodules, run by China-Japan Friendship Hospital 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 8 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: looking for participants now, as of the sponsor's last update on 18 Dec 2024. 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 Guangying Zhu, doctor (+86-010-84205381, zryyfa@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish an model for differentiating lung nodules. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2024.