NCT06699979招募中不适用
Comprehensive Multi-Omics Analysis of Early-Stage Lung Cancer Exhibiting Distinct Phenotypes
Central South University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年8月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Immune repertoire sequencing
研究概览
简要总结
The goal of this observational study is to investigate the multi-omics characterization early-stage lung cancer exhibiting distinct phenotypes including lung cancer associated with cystic airspaces, multiple primary lung cancers, and so on. The main questions it aims to answer are:
- What are the differences in pathogenesis of non-small cell lung cancer with different phenotypes explored by multi-omics?
- Whether differential genes lead to potential prognostic models and therapeutic targets? Participants will be followed up after surgery to answer prognosis: whether they have recurred, and the time to recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cohort 1: Multi-omics study in early-stage synchronous multiple primary lung cancer
- •Inclusion criteria:
- •Male or female patients:18-75 years old;
- •ECOG score:0-1;
- •Histopathologically confirmed TNM stage I-II NSCLC;
- •Considered multiple or solitary primary lung cancer by clinical criteria (Martini-Melamed criteria and ACCP criteria);
- •Good compliance, family members agree to cooperate to receive survival follow-up;
- •Understand and voluntarily sign the informed consent.
排除标准
- •A history of previous or co-existing malignant tumors;
- •Systemic anti-tumor therapies, including chemotherapy, radiotherapy, or targeted therapies (such as monoclonal antibodies, small-molecule tyrosine kinase inhibitors, among others), were administered prior to enrollment;
- •Refusal to participate in the study.
- •Cohort 2: Multi-omics study of lung cancer associated with cystic airspaces
- •Inclusion criteria:
- •Male or female patients:18-75 years old;
- •ECOG score:0-1;
- •Histopathologically confirmed TNM stage I-II NSCLC;
- •CT findings show solitary or multiple nodules with cystic airspaces.
- •Exclusion criteria:
- •A history of previous or co-existing malignant tumors;
- •Systemic anti-tumor therapies, including chemotherapy, radiotherapy, or targeted therapies (such as monoclonal antibodies, small-molecule tyrosine kinase inhibitors, among others), were administered prior to enrollment;
- •Refusal to participate in the study.
研究组 & 干预措施
Non-small cell lung cancer
Early-stage lung cancer exhibiting distinct phenotypes including lung cancer associated with cystic airspaces, multiple primary lung cancers, and so on.
结局指标
主要结局
Immune repertoire sequencing
时间窗: From enrollment to the end of surgery for 3 years
DNA methylome sequencing
时间窗: From enrollment to the end of surgery for 3 years
RNA sequencing
时间窗: From enrollment to the end of surgery for 3 years
次要结局
- Genomic sequencing(From enrollment to the end of surgery for 3 years)
- Metabolomics analysis(From enrollment to the end of surgery for 3 years)
- Radiomics analysis(From enrollment to the end of surgery for 3 years)
研究者
Chen Chen
Associate Professor
Second Xiangya Hospital of Central South University
研究点 (1)
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