Research and Development Study: Tissue Collection From Patients Who Are Undergoing Surgery for Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 7
研究概览
简要总结
A 15-gene lung signature was created to identify predictive and prognostic biomarkers for Non-Small Cell Lung Cancer (NSCLC) patients. The 15-gene signature was validated using a microarray platform with fresh frozen tumor tissue to place NSCLC patients into high risk and low risk cohorts with significantly different survivals.
Using fresh frozen tissue can be challenging, so this study attempts simplify the process by migrating the 15-gene signature from fresh frozen to two alternative tissue formats: Formalin Fixed Paraffin Embedded (FFPE) and RNAlater.
The gene expressions of the different tissue formats will be compared to see if the fresh frozen tissue results are similar to the alternative tissue formats.
详细描述
Patients with early stage NSCLC will be consented prior to surgery so that any excess tissue collected during surgery can be collected in one of the three tissue formats (Fresh Frozen, FFPE, RNAlater) and sent to the Sponsor for testing.
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
- •New diagnosis of stage I or II Non-Small Cell Lung Cancer (NSCLC)
- •Must have resectable disease and complete surgical resection planned
- •Histologically or cytologically confirmed adenocarcinoma, squamous or large cell carcinoma NSCLC
- •No prior chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer
- •Tumor specimen samples must be collected within 1 hour of surgery
- •Patient must be at least 18 years of age
- •Patient must sign and date an approved study consent form
排除标准
- •Patients with psychiatric or addictive disorders that would preclude obtaining study consent
- •Informed consent obtained the same day as surgery
- •Absence of histological diagnosis of lung cancer
- •Known infectious disease
- •History of chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer or any prior cancer or any other non-cancer diseases or illnesses, i.e. rheumatoid arthritis