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Development and Clinical Translational Research of an Early Screening System for Lung Cancer-Associated Gene Methylation Based on Electrochemical-Surface Plasmon Resonance (ESPR) Technology

Development and Clinical Translational Research of an Early Screening System for Lung Cancer-Associated Gene Methylation Based on Electrochemical-Surface Plasmon Resonance (ESPR) Technology

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114964
Enrollment
Unknown
Registered
2025-12-19
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Gold Standard:Pathological diagnosis
Index test:Early Screening System for Lung Cancer-Related Gene Methylation Based on Electrochemical-Surface Plasmon Resonance Technology (ESPR)

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Retrospective Cohort 1. Healthy Control Group (N = 124): No history of lung cancer or family history of tumors before sample collection, and no long-term smoking history (smoking index = 20 pack-years; first-degree relative with a family history of lung cancer; presence of COPD, diffuse pulmonary fibrosis, or old pulmonary tuberculosis; history of previous malignancy; long-term exposure to secondhand smoke (at home or workplace, >2 hours/day, for at least 10 years) or long-term exposure to kitchen cooking fumes (stir-frying, pan-frying, deep-frying, etc.).

Exclusion criteria

Exclusion criteria: Retrospective Cohort Healthy Control Group (N = 124): coexisting with other malignant tumors; severe immunosuppression; pregnancy/lactation; received blood transfusion or immunotherapy within 1 month before blood collection. Early Lung Cancer Group (N = 124): coexisting with other malignant tumors; HIV infection or post-organ transplantation; used demethylating agents within 72 hours before sample collection. Prospective Cohort 1. Coexisting with other malignant tumors not clinically cured; 2. Severe immunosuppression; 3. Pregnancy/lactation; 4. Received blood transfusion or immunotherapy within 1 month before blood collection; 5. HIV infection or post-organ transplantation.

Design outcomes

Primary

MeasureTime frame
Methylation levels of lung cancer-related genes;Sensitivity;Specificity;Positive Predictive Value (PPV);Negative Predictive Value (NPV);Hazard Ratio (HR) ;

Countries

China

Contacts

Public ContactLi Lin

Beijing Hospital

lilin_51@hotmail.com+86 136 0122 7591

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026