Developing a urine test for early lung cancer detection
Urine Proteomic Precision Diagnosis Model for Early Stage Lung Cancer
This study is trying to see if a new urine test can help find early-stage lung cancer more accurately than current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 480 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing Chao Yang Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Chaoyang District, Beijing) |
| Trial ID | NCT06733311 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with suspected early-stage non-small cell lung cancer (NSCLC) who have not received prior cancer treatment.
Not a fit: Patients with metastatic disease or those who have undergone any form of cancer treatment prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of lung cancer, potentially improving patient outcomes.
How similar studies have performed: While the approach of using urine proteomics for cancer detection is innovative, similar studies have shown promise in other cancers, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chaoyang District, Beijing
- Beijing Chao-Yang Hospital, Capital Medical University — Chaoyang District, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Bin Hu, MD
- Phone: +86 139-0130-1750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.