Analysis of Cell Count, Viability, and Immunogenicity of Deidentified Discarded Newly Diagnosed Glioblastoma Tissue and More Broadly Other Newly Diagnosed Solid Tumor Tissues From the Operating Room
概览
- 阶段
- 不适用
- 干预措施
- Biospecimen Collection
- 疾病 / 适应症
- Glioblastoma
- 发起方
- Thomas Jefferson University
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Cell yield
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
This study examines tumor tissues and blood samples to aid in the development of therapies for brain cancer and other solid tumors. Studying samples of blood and tissue from patients with glioblastoma or other solid tumor in the laboratory may help doctors understand brain tumors and better inform future treatments.
详细描述
PRIMARY OBJECTIVES: I. Assessment of cell yield and percentage of viable cells upon tissue receipt at the cell processing facility. II. Obtain discarded tumor tissue from surgical resections for further studies to aid in development of future therapies for glioblastoma (GBM) and other solid tumors. SECONDARY OBJECTIVE: I. Assessment of cell yield and percentage of viable cells from other solid tumor cells shipped to the cell processing facility. EXPLORATORY OBJECTIVE: I. An additional line of inquiry will be devoted to scientific exploration of the product's immunogenicity looking at important variables in the course of manufacture. OUTLINE: Patients undergo collection of tissue sample during surgery. Patients also undergo collection of blood sample.
研究者
入排标准
入选标准
- •Provide signed and dated informed consent form
- •Any individual \>= 18 years old
- •Patients must have GBM or other solid tumor and undergoing surgery for diagnostic and therapeutic purposes
排除标准
- •Individuals less than 18 years old
- •Unable to understand and give consent
- •Patients who are not surgical candidates
研究组 & 干预措施
Basic Science (Biospecimen collection)
Patients undergo collection of tissue sample during surgery. Patients also undergo collection of blood sample.
干预措施: Biospecimen Collection
结局指标
主要结局
Cell yield
时间窗: At study completion, up to 12 months
This will be determined for each sample. Cell yield data is measured in 106and is assumed to be normally distributed. Summary statistics of mean, standard deviation, 95% confidence interval and range will be reported.
Percentage cell viability
时间窗: At study completion, up to 12 months
Percentage cell viability will be calculated by the number of viable cells divided by the cell yield. The mean will be computed using the sum of the viable cells divided by the sum of cell yield. The range of percentage cell viability and 95% confidence interval will be provided.