The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 797
- 试验地点
- 9
- 主要终点
- Ratio of each molecular subtypes
研究概览
简要总结
This protocol is a molecular screening protocol only. No drug intervention study will be included in this protocol. Based on the molecular profiling, patients may be eligible for drug intervention study of SUKSES trial.
This procedure can be performed during or after the first-line treatment. DNA will be extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring CNV will be tested with DNA from tissue and/or blood.
Immunohistochemistry and FISH will be done by pathologists using archived or fresh tissue.
Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH.
Specific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.
详细描述
This protocol is a molecular screening protocol only. No drug intervention study will be included in this protocol. Based on the molecular profiling, patients may be eligible for drug intervention study of SUKSES trial.
This procedure (molecular profiling) can be performed before, during, or after the initial treatment.
DNA will be extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring CNV will be tested with DNA from tissue and/or blood.
Immunohistochemistry and FISH will be done by pathologists using archived or fresh tissue.
In addition, blood collection will be conducted at Baseline (initial), three weeks, six weeks, twelve weeks, and subsequent imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of fully informed consent prior to any study specific procedures.
- •Patients must be ≥20 years of age.
- •Histologically or cytologically confirmed Small cell lung cancers
- •ECOG performance status of 0 to 2
- •Patients who are being treated or were treated with platinum-based chemotherapy as a first-line treatment
- •Patients with available archival tissues for molecular analysis or patients who agreed with biopsy for molecular analysis
排除标准
- •More than two prior chemotherapy regimen for the treatment of small cell lung cancer
- •Pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method)
- •Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤2 years.
研究组 & 干预措施
Small cell lung cancers
To provide molecular characteristics of Small cell lung cancers to proceed SUKSES trial, To assess success rate of molecular profiling of Small cell lung cancers
干预措施: No treatment is included in this protocol. (Other)
结局指标
主要结局
Ratio of each molecular subtypes
时间窗: After registration of this study
To provide molecular characteristics of SCLC to proceed SUKSES trial
次要结局
- Success rate of each molecular profiling methods(After completion of registration)
研究者
Se-Hoon Lee
MD,PhD
Samsung Medical Center