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RecruitingNCT06778512Updated Jan 16, 2025

LcProt: Proteomics Longitudinal Cohort Study on Lung Cancer

An observational study in Lung, Lung Cancer and Cancer, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-16.

Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Observational

From the registry’s dates

  • Started Jun 2019; still recruiting 7 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lung
  • Lung Cancer
  • Cancer
  • NSCLC

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Keywords

  • Lung cancer
  • Proteomics
  • Protein
  • NSCLC
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with lung nodules confirmed by CT examination.

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

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • OtherUsing 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

    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

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What researchers measure

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).

    Time frame: 3 years

Secondary outcomes

  1. Differentially Expressed Proteins

    Differential proteins, or differentially expressed proteins (DEPs), refer to proteins that show significant changes in expression levels between different biological or experimental conditions, such as disease vs. healthy states, treated vs. untreated groups, or across time points in longitudinal studies. These proteins are identified through quantitative proteomics techniques, including mass spectrometry or label-free methods, and analyzed using statistical or bioinformatics tools to determine significance.

    Time frame: 3 years

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Study locations

1 of 1 sites recruiting
  • the First Affiliated of Guangzhou Medical University
    Guangzhou, Guangdong 510120, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06778512
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Responsible party
Jianxing He (Professor, The First Affiliated Hospital of Guangzhou Medical University) — Principal investigator
First posted
Jan 16, 2025
Start date
Jun 1, 2019
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jan 16, 2025

Study contacts

Jianxing He, Professor
Contact
drjiaxing.he@gmail.com
86-20-83337792

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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