Developing a urine test for early lung cancer detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to create a non-invasive urine proteomic diagnostic model to enhance early-stage lung cancer detection. Participants will provide preoperative urine samples, which will undergo proteomic analysis. The study will integrate clinical, imaging, and proteomic data into an AI-assisted diagnostic model to evaluate its sensitivity and specificity compared to current diagnostic methods. The goal is to identify biomarkers associated with early-stage lung cancer and validate the accuracy of the new diagnostic approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Chao-Yang Hospital, Capital Medical University
  Chaoyang District, Beijing, China Recruiting

Study contacts

• Study coordinator: Bin Hu, MD
• Phone: +86 139-0130-1750

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.