A Multi-omics Sequencing-based Model for Predicting Efficacy and Dynamic Monitoring of Treatment in Small Cell Lung Cancer
Recruiting · NCT07026669 · Observational (researchers observe without assigning treatment) · Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- Patients meeting the following criteria may have samples collected:
- Voluntary signing of informed consent;
- Age ≥18 years;
- Expected survival time ≥3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Treatment-naïve limited-stage or extensive-stage SCLC confirmed by histology or cytology;
- Agreement to provide blood samples and paraffin-embedded samples;
- Measurable target lesions for efficacy evaluation.
Exclusion criteria
- Patients with any of the following conditions will be excluded from sample collection:
- 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;
- Investigator-determined unsuitability for peripheral blood collection due to complications or other conditions;
- Active, known, or suspected autoimmune disease (excluding vitiligo, type I diabetes, residual hypothyroidism caused by autoimmune thyroiditis requiring only hormone replacement therapy, or conditions not expected to recur without external stimulation);
- Active tuberculosis (TB) infection based on chest X-ray, sputum examination, and clinical examination. Patients with active pulmonary TB infection history within the previous year should be excluded even if treated. Patients with active pulmonary TB infection history more than one year ago should also be excluded unless previous anti-TB treatment can be proven adequately effective;
- Comorbidities requiring immunosuppressive drug treatment, or requiring systemic or local corticosteroid use at immunosuppressive doses;
- Pregnancy or lactation;
- Positive human immunodeficiency virus antibody (HIVAb), active hepatitis B virus infection (HBsAg positive and HBV-DNA \>10³ copies/ml), or hepatitis C virus infection (HCV antibody positive and HCV-RNA \> lower limit of detection at study center);
- History of severe neurological or psychiatric disorders, including but not limited to: dementia, depression, seizures, bipolar disorder, etc.;
- Use of any anti-tumor drugs before blood sample collection;
- Previous history of other malignant tumors (excluding non-melanoma skin cancer and the following carcinoma in situ: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast cancer);
- Patients receiving live vaccines within 28 days before blood sample collection.
Where it is running
1 location listed.
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College - Beijing, Beijing Municipality, China