LcProt: Proteomics Longitudinal Cohort Study on Lung Cancer

NCT06778512 | Recruiting

• 2 other identifiers: LcProtES-2924-051-02
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

This study will utilize tissue and peripheral blood samples for proteomics analysis and establish a longitudinal proteomics cohort at multiple critical treatment time points to explore the research value of proteomics in the diagnosis and treatment of lung cancer. The study includes key time points such as screening, postoperative efficacy prediction, and efficacy prediction after medication.

Conditions

Lung; Lung Cancer; Cancer; NSCLC

Keywords

Lung cancer; Proteomics; Protein; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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. In clinical studies, AUC is often used to assess diagnostic tests, where a higher AUC indicates better test accuracy in distinguishing between conditions (e.g., disease vs. no disease).

  3 years

Secondary Outcomes (1)

• Differentially Expressed Proteins

  3 years

Interventions

Using tissue and peripheral blood proteomics to distinguish the benign and malignant nature of lung cancer in patients, as well as to evaluate therapeutic efficacy and long-term prognosis during the t OTHER

Peripheral blood samples from enrolled participants will be drawn, or lesion tissues will be obtained through procedures such as biopsy or surgery, followed by quantitative proteomics analysis using mass spectrometry.

Also known as: Draw peripheral blood, Obtain lesion tissue

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lung nodules confirmed by CT examination.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

the First Affiliated of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jianxing He, Professor

CONTACT

86-20-83337792; drjiaxing.he@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 16, 2025
• Study Start: June 1, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

CN (1)