Urine Proteomic Precision Diagnosis Model for Early Stage Lung Cancer
Status: Recruiting
Location: See location...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
⁃ Male or female participants aged 18 to 75 years.
⁃ Diagnosed or highly suspected early-stage (I-IIIA, non-N2) non-small cell lung 3.cancer (NSCLC) based on imaging or clinical assessment.
• No prior anti-cancer treatment, including surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
• Able to provide informed consent and willing to comply with the study protocol, including urine sample collection before surgery.
• Diagnosis confirmed within 42 days post-imaging or preoperative assessment through biopsy or surgical specimen.
Locations
Other Locations
China
Beijing Chao-Yang Hospital, Capital Medical University
RECRUITING
Chaoyang District
Contact Information
Primary
Bin Hu, MD
+86 139-0130-1750
Time Frame
Start Date:2024-03-01
Estimated Completion Date:2024-12-31
Participants
Target number of participants:480
Treatments
Urine Proteomics Diagnostic Group
Participants in this group will undergo urine proteomic analysis before surgery to predict early-stage non-small cell lung cancer (NSCLC). The predictions include tumor histopathological subtypes, lymph node metastasis, and other pathological factors. The accuracy of the diagnostic model will be compared to pathological results after surgery. This group consists of approximately 240 participants, with an anticipated 10% loss accounted for.
CT Diagnostic Group
Participants in this group will undergo standard preoperative chest CT imaging to predict early-stage non-small cell lung cancer (NSCLC). Predictions include tumor histopathological subtypes, lymph node metastasis, and other pathological factors. The accuracy of the imaging predictions will be compared to pathological results after surgery. This group also consists of approximately 240 participants, with an anticipated 10% loss accounted for.