A Multi-omics Sequencing-based Model for Predicting Efficacy and Dynamic Monitoring of Treatment in Small Cell Lung Cancer
Trial Parameters
Brief Summary
Lung cancer is one of the malignant tumors with the highest incidence and mortality rates globally, with small cell lung cancer (SCLC) accounting for approximately 15%. SCLC is characterized by high malignancy, propensity for metastasis and drug resistance, and a 5-year survival rate below 7%. Despite partial progress in chemotherapy and immunotherapy, SCLC patients generally have extremely poor prognosis, and there is a lack of precise therapeutic efficacy prediction and dynamic monitoring approaches. Existing biomarkers (such as TP53/RB1 mutations) are inadequate for clinical needs due to high heterogeneity and insufficient dynamic characteristics. The rapid development of multi-omics technologies provides new opportunities for analyzing SCLC molecular features; however, previous studies have predominantly focused on single omics approaches with insufficient systematic integration, limiting clinical translation. This study aims to systematically integrate multiple omics technologies to construct predictive and dynamic monitoring models for SCLC therapeutic efficacy, providing new methods and evidence for SCLC clinical treatment and dynamic monitoring.
Eligibility Criteria
Inclusion Criteria: * Patients meeting the following criteria may have samples collected: 1. Voluntary signing of informed consent; 2. Age ≥18 years; 3. Expected survival time ≥3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 5. Treatment-naïve limited-stage or extensive-stage SCLC confirmed by histology or cytology; 6. Agreement to provide blood samples and paraffin-embedded samples; 7. Measurable target lesions for efficacy evaluation. Exclusion Criteria: * Patients with any of the following conditions will be excluded from sample collection: 1. Archived tumor tissue or pre-treatment tumor biopsy or histological examination showing previous histological or cytological evidence of non-small cell or small cell/non-small cell mixed components; 2. Investigator-determined unsuitability for peripheral blood collection due to complications or other conditions; 3. Active, known, or suspected autoimmune disease (excluding vitiligo, type I diabetes, re