Lung CancerNCT06843707
Establishing a Longitudinal Cohort Study of Lung Cancer Using Tissue and Peripheral Blood Metabolomics.
An observational study of Lung Cancer and Lung, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study will utilize tissue and peripheral blood samples for metabolomics analysis and establish a longitudinal metabolomics cohort at multiple critical treatment time points to comprehensively investigate the role of metabolomics in the diagnosis, prognosis, and therapeutic monitoring of lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Lung, Lung Cancer (NSCLC)
- What is being tested?
- Monitoring serum metabolites in lung cancer patients using tissue and peripheral blood samples.
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2027
- How long will I take part?
- 5 Years
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lung nodules confirmed by CT examination.
Who may be able to join
- Signing of the informed consent form;
- Male or female, aged 18-75 years;
- Patients with lung nodules confirmed by CT examination;
- Good preoperative pulmonary function cooperation and complete reporting;
- Preoperative chest single/dual phase CT scans without significant artefacts and with complete imaging;
- The interval between preoperative pulmonary function and single/dual phase CT scans does not exceed one month.
Who cannot join
- Poor preoperative pulmonary function cooperation or missing reports;
- Preoperative chest single/dual phase CT scans exhibit significant artefacts or image omission;
- The interval between preoperative pulmonary function and single/dual phase CT scans exceeds one month;
- Complication with severe respiratory disorders (such as lung transplantation, pneumothorax, giant bullae, etc.);
- Coexisting with other severe functional impairments;
- Patients with obstructive lesions such as airway or esophageal stenosis;
- Medication use before pulmonary function testing that does not meet the cessation guidelines; (9) Pulmonary function report quality graded D-F.
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
the First Affiliated of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official title: Establishing a Longitudinal Cohort Study of Lung Cancer Using Tissue and Peripheral Blood Metabolomics to Explore Biomarkers and Therapeutic Mechanisms.
This study will utilize tissue and peripheral blood samples for metabolomics analysis and establish a longitudinal metabolomics cohort at multiple critical treatment time points to comprehensively investigate the role of metabolomics in the diagnosis, prognosis, and therapeutic monitoring of lung cancer. By profiling metabolic alterations, this study aims to identify potential biomarkers for distinguishing benign and malignant lung nodules, predicting therapeutic efficacy, and assessing long-term prognosis. Key time points include initial screening for lung nodules, postoperative evaluation to predict treatment outcomes, and therapeutic monitoring to assess efficacy after medication or other interventions. Through these analyses, the study seeks to uncover underlying metabolic mechanisms and provide valuable insights into personalized lung cancer management.
- Conditions
- Lung Cancer, Lung, Lung Cancer (NSCLC), Metabolomics
- Being tested
- Monitoring serum metabolites in lung cancer patients using tissue and peripheral blood samples.
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring serum metabolites in lung cancer patients using tissue and peripheral blood samples.Other
This study focuses on monitoring serum metabolites in lung cancer patients by utilizing tissue and peripheral blood samples. By analyzing the metabolic profiles of serum, the research aims to identify significant metabolic alterations associated with lung cancer progression, treatment response, and overall prognosis. The study seeks to provide a comprehensive understanding of how metabolic changes in serum reflect disease dynamics and therapeutic outcomes, ultimately contributing to the development of more accurate diagnostic and prognostic biomarkers for lung cancer management.
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve
AUC, or Area Under the Curve, is a commonly used metric in statistical and machine learning models, particularly for evaluating the performance of classification models. It refers to the area under the Receiver Operating Characteristic (ROC) curve, which plots the true positive rate (sensitivity) against the false positive rate (1-specificity) at various threshold settings. An AUC value ranges from 0 to 1, where:
- 1 indicates a perfect model,
- 0.5 suggests a model no better than random guessing,
- < 0.5 reflects a model performing worse than random.
Measured: 3 Years
Secondary outcomes (1)
Differentially Expressed Metabolites
Differential metabolites, or differentially expressed metabolites (DEMs), refer to metabolites that show significant changes in abundance between different biological or experimental conditions, such as disease vs. healthy states, treated vs. untreated groups, or across time points in longitudinal studies. These metabolites are identified through quantitative metabolomics techniques, including mass spectrometry or nuclear magnetic resonance (NMR), and analyzed using statistical or bioinformatics tools to determine significance.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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
- 2,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843707
- Sponsor's protocol ID
- LungMet
- Other IDs
- 2025-01-12
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Longitudinal Cohort Study of Lung Cancer Using Tissue and Peripheral Blood Metabolomics to Explore Biomarkers and Therapeutic Mechanisms.
- ClinicalTrials.gov ID
- NCT06843707
- Acronym / sponsor ID
- LungMet
- Conditions
- Lung Cancer, Lung, Lung Cancer (NSCLC), Metabolomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Feb 2025 (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.
This study will utilize tissue and peripheral blood samples for metabolomics analysis and establish a longitudinal metabolomics cohort at multiple critical treatment time points to comprehensively investigate the role of metabolomics in the diagnosis, prognosis, and therapeutic monitoring of lung cancer. By profiling metabolic alterations, this study aims to identify potential biomarkers for distinguishing benign and malignant lung nodules, predicting therapeutic efficacy, and assessing long-term prognosis. Key time points include initial screening for lung nodules, postoperative evaluation to predict treatment outcomes, and therapeutic monitoring to assess efficacy after medication or other interventions. Through these analyses, the study seeks to uncover underlying metabolic mechanisms and provide valuable insights into personalized lung cancer management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung nodules confirmed by CT examination.
Key inclusion criteria (6 listed)
- Signing of the informed consent form;
- Male or female, aged 18-75 years;
- Patients with lung nodules confirmed by CT examination;
- Good preoperative pulmonary function cooperation and complete reporting;
- Preoperative chest single/dual phase CT scans without significant artefacts and with complete imaging;
Key exclusion criteria (7 listed)
- Poor preoperative pulmonary function cooperation or missing reports;
- Preoperative chest single/dual phase CT scans exhibit significant artefacts or image omission;
- The interval between preoperative pulmonary function and single/dual phase CT scans exceeds one month;
- Complication with severe respiratory disorders (such as lung transplantation, pneumothorax, giant bullae, etc.);
- Coexisting with other severe functional impairments;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring serum metabolites in lung cancer patients using tissue and peripheral blood samples.This study focuses on monitoring serum metabolites in lung cancer patients by utilizing tissue and peripheral blood samples. By analyzing the metabolic profiles of serum, the research aims to identify significant metabolic alterations associated with lung cancer progression, treatment response, and overall prognosis. The study seeks to provide a comprehensive understanding of how metabolic changes in serum reflect disease dynamics and therapeutic outcomes, ultimately contributing to the development of more accurate diagnostic and prognostic biomarkers for lung cancer management. | Other | – |
Primary outcome
Area Under the Curve
Time frame: 3 Years
AUC, or Area Under the Curve, is a commonly used metric in statistical and machine learning models, particularly for evaluating the performance of classification models. It refers to the area under the Receiver Operating Characteristic (ROC) curve, which plots the true positive rate (sensitivity) against the false positive rate (1-specificity) at various threshold settings. An AUC value ranges from 0 to 1, where: * 1 indicates a perfect model, * 0.5 suggests a model no better than random guessing, * < 0.5 reflects a model performing worse than random.
1 secondary outcome
Differentially Expressed Metabolites
Time frame: 3 years
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 25 Feb 2025.
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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 Lung Cancer and Lung, run by The First Affiliated Hospital of Guangzhou Medical University 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 6 inclusion and 7 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 25 Feb 2025. 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 Jianxing He, Professer (86-20-83337792, drjiaxing.he@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (time frame: 3 Years). 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 25 Feb 2025.