A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction
研究概览
简要总结
The purpose of this study is to learn whether it is better to receive the drug Metformin with standard of care for lung cancer or just standard of care.
详细描述
Participants will need to be scheduled to undergo a surgical resection of their lung cancer at the Mayo Clinic in Rochester, Minnesota. They will be asked to provide a blood sample prior to their surgery. Samples of tumor tissue and normal lung tissue will be taken from the samples removed during your lung surgery. The tissue will be used to evaluate DNA. A skin biopsy at the edge of the incision that has already been made will be done during your surgery. We will take the skin and grow skin fibroblasts. Then we will reprogram the skin fibroblasts into induced pluripotent cells. You will be "randomized" into one of the study groups to either take Metformin for 6 months with your standard of care follow up or to receive standard of care follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Metformin
Metformin 850mg twice a day
干预措施: Metformin (Drug)
Observation
Standard of Care Observation
干预措施: Placebo Comparator (Other)
结局指标
主要结局
Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction
时间窗: 2 years
To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected.
Number of Participants With 2-year Recurrence Free Survival
时间窗: 4 years
To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.
次要结局
- Number of Participants With Adverse Events as a Measure of Safety(4 years)
- Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)(4 years)