Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer (CTMS 18-0056)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- To establish and characterize a biobank of patient-derived organoids (PDOs), and investigate the potential of PDOs to recapitulate ex vivo responses to chemotherapeutic and targeted agents observed in the clinic.
研究概览
简要总结
Create a living biobank of PDOs from Stage I-III lung cancer patients.
详细描述
Creation a living biobank of PDOs from Stage I-IV lung cancer patients (n=50). We selected enrollment of at least 50 patients so that they can be risk stratified based on lung tumor type, staging and we plan to store these PDOs in biobank for future experiments. For each patient, tumor specimens will be collected at time of their surgery. No specific therapeutic intervention or treatment is provided as part of this study.
- Establishment and culture of PDOs from lung cancer tumor specimens. PDOs will be biobanked for future experiments.
- Lung organoids and CTCs will also be cultured and used to study baseline tumor characteristics using histology, immunohistochemistry, atomic force measurements; as well as, oncogenic signaling pathways and proteomic profile of lung organoids and CTCs derived from lung cancer patients (n>50).
- Patient demographic information and data to be collected using a patient survey data sheet with treatment and survival history collected at pre-defined time period per the protocol schedule.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Read, consented to and signed the IRB-approved informed consent form prior to any study related procedure.
- •Diagnosis of lung cancer or lung mass or lymphadenopathy that will either systemic treatment or tumor resection as part of standard of care
- •Any clinical stage of lung cancer
- •Adult patients ≥18 years of age
- •Able and willing to complete a questionnaire on their environmental/occupational exposures and smoking/alcohol history
排除标准
- •At the discretion of the treating physician, patient will not be able to fulfill the requirements of the study.
结局指标
主要结局
To establish and characterize a biobank of patient-derived organoids (PDOs), and investigate the potential of PDOs to recapitulate ex vivo responses to chemotherapeutic and targeted agents observed in the clinic.
时间窗: 10 years
Establishment of a living biobank of PDOs and the potential of PDOs to repeat their process outside a living organism
次要结局
- Correlation of PDO and Circulating tumor cells (CTCs)(10 years)
研究者
Josephine Taverna
Principal Investigator
The University of Texas Health Science Center at San Antonio