A Study Developing a Non-invasive Urine-based Proteomic Model for Early Lung Cancer Detection.

Recruiting

• Conditions: Early-Stage Lung Cancer; Pulmonary Nodule; NSCLC

• Registration Number: NCT06733311
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

Brief Summary:

The goal of this observational study is to develop a non-invasive urine proteomic diagnostic model to improve early-stage lung cancer detection. The study aims to answer the following main questions:

Can urine proteomics reliably differentiate early-stage lung cancer from benign conditions? How does the diagnostic model compare to current clinical and imaging methods in accuracy?

Participants will:

Provide preoperative urine samples. Undergo proteomic analysis of urine samples. Have clinical, imaging, and proteomic data integrated into an AI-assisted diagnostic model.

The study will evaluate the sensitivity and specificity of this innovative diagnostic approach.

Detailed Description

Detailed Description:

This study focuses on developing a urine proteomic-based diagnostic model to improve the early detection of lung cancer. It leverages non-invasive urine sampling, proteomic analysis, and artificial intelligence to create a high-sensitivity, high-specificity diagnostic tool.

The study will recruit 480 participants with suspected early-stage lung cancer (I-IIIA, non-N2). Urine samples will be collected before surgery, and participants will undergo standard imaging and diagnostic evaluations, including chest CT, abdominal ultrasound or CT, brain MRI or CT, and bone scans.

The primary objectives of the study include:

1. Biomarker Identification: Identifying differentially expressed urine proteins associated with early-stage lung cancer.

2. Diagnostic Model Construction: Combining proteomic findings with clinical and imaging data to construct a diagnostic model using AI-based algorithms.

3. Validation: Evaluating the model's diagnostic accuracy compared to current clinical practices.

Participants will contribute to the advancement of a novel diagnostic method that aims to minimize unnecessary invasive procedures and improve lung cancer prognosis through early and accurate detection.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-03-01
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

1. Male or female participants aged 18 to 75 years.
2. Diagnosed or highly suspected early-stage (I-IIIA, non-N2) non-small cell lung 3.cancer (NSCLC) based on imaging or clinical assessment.

4.No prior anti-cancer treatment, including surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.

5.Able to provide informed consent and willing to comply with the study protocol, including urine sample collection before surgery.

6.Diagnosis confirmed within 42 days post-imaging or preoperative assessment through biopsy or surgical specimen.

Exclusion Criteria

1. History of any cancer treatment prior to study enrollment.
2. Presence of metastatic disease (N2 or more advanced staging).
3. Severe comorbid conditions or organ dysfunctions (e.g., renal failure) that could affect urine sample quality or interpretation.
4. Pregnancy or lactation.
5. Participation in another clinical study that could interfere with the outcomes of this study.
6. Inability to comply with the study protocol, including language barriers or cognitive impairments.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prediction Accuracy of Diagnostic Models	Within 2 weeks post-surgery.	The primary outcome measure is the accuracy of preoperative predictions (sensitivity and specificity) for early-stage non-small cell lung cancer (NSCLC) diagnosis. Predictions are based on: 1. Urine proteomics in the experimental group.; 2. Chest CT imaging in the control group.; Accuracy will be assessed by comparing preoperative predictions with postoperative pathological findings, including tumor histopathological subtypes, lymph node metastasis, and other pathological factors.

Secondary Outcome Measures

Name	Time	Method
Cut-off Value for Urine Proteomics Diagnostic Test	Within 1 month after data analysis.	Determination of the optimal cut-off value for urine proteomic markers to maximize diagnostic sensitivity and specificity for early-stage non-small cell lung cancer (NSCLC).
Comparative Performance of Diagnostic Models	Within 2 months post-surgery.	Evaluation of the diagnostic performance (sensitivity, specificity, and area under the curve \[AUC\]) of the urine proteomic model versus chest CT imaging for predicting tumor histopathological subtypes, lymph node metastasis, and staging.
Long-term Diagnostic Effectiveness	Up to 2 years post-surgery.	Evaluation of the correlation between preoperative diagnostic accuracy and 2-year postoperative clinical outcomes (e.g., recurrence rates, survival outcomes).

Trial Locations

Locations (1)

Beijing Chao-Yang Hospital, Capital Medical University; 🇨🇳 Chaoyang District, Beijing, China