Clinical trial NCT06843707: Establishing a Longitudinal Cohort Study of Lung Cancer Using Tissue and Peripheral Blood Metabolomics.
Official title: Establishing a Longitudinal Cohort Study of Lung Cancer Using Tissue and Peripheral Blood Metabolomics to Explore Biomarkers and Therapeutic Mechanisms.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lung
Lung Cancer (NSCLC)
Metabolomics
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lung nodules confirmed by CT examination.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Signing of the informed consent form;
2. Male or female, aged 18-75 years;
3. Patients with lung nodules confirmed by CT examination;
4. Good preoperative pulmonary function cooperation and complete reporting;
5. Preoperative chest single/dual phase CT scans without significant artefacts and with complete imaging;
6. The interval between preoperative pulmonary function and single/dual phase CT scans does not exceed one month.

Exclusion Criteria:

1. Poor preoperative pulmonary function cooperation or missing reports;
2. Preoperative chest single/dual phase CT scans exhibit significant artefacts or image omission;
3. The interval between preoperative pulmonary function and single/dual phase CT scans exceeds one month;
4. Complication with severe respiratory disorders (such as lung transplantation, pneumothorax, giant bullae, etc.);
5. Coexisting with other severe functional impairments;
6. Patients with obstructive lesions such as airway or esophageal stenosis;

(8) Medication use before pulmonary function testing that does not meet the cessation guidelines; (9) Pulmonary function report quality graded D-F.

Primary outcomes:
measure: Area Under the Curve
timeFrame: 3 Years
Secondary outcomes:
measure: Differentially Expressed Metabolites
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated of Guangzhou Medical University
state: Guangdong
Study officials:
References: