Tumor Gene Expression Before and After Intraoperative Dexamethasone in Women With Ovarian Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Increase in SGK1 mRNA Expression Level
研究概览
简要总结
The study objective is to compare changes in expression of glucocorticoid-induced genes that may be involved in cell survival signaling in the tumors of ovarian cancer patients before and after an intraoperative dose of 20mg dexamethasone.
详细描述
This trial will examine the upregulation of dexamethasone-inducible genes in the tumors of ovarian cancer patients undergoing surgical debulking. A core biopsy of tumor will be taken at the first opportune time during surgery. Dexamethasone 20 mg IV will then be administered, and a second biopsy taken 30 minutes later. Samples at two and four hours later will also be obtained if surgery is still in progress and biopsiable tumor remains. Tissue will be snap-frozen. Subsequently tumor will be microdissected out from stroma, and tumor RNA will be extracted for gene expression profiling. Sixteen patients with epithelial ovarian cancer receiving dexamethasone will be studied, and an additional eight patients with epithelial ovarian cancer will receive a small saline (placebo) injection and serve as controls. Enrollment is limited to those patients with a serum albumin of at least 3.0 g/dL to minimize any theoretical adverse effect of a single dose of dexamethasone on wound healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject has intraabdominal disease either proven or strongly suspected to be ovarian or primary peritoneal cancer, and will be undergoing surgical debulking.
- •Subject is not allergic to dexamethasone, and there is no obvious medical contraindication to dexamethasone.
- •Subjects with diabetes requiring drug therapy are excluded.
- •Subject is not currently receiving glucocorticoid therapy
- •Nasal steroids (e.g. Flonase) are permitted
- •Subject understands that this protocol does not have therapeutic intent
- •Preoperative serum albumin at least 3.0 mg/dL
- •Negative serum or urine pregnancy test in women of childbearing potential
- •Signed informed consent
排除标准
- •Males do not get ovarian cancer and therefore will not be included in this trial.
- •Patients of all ethnic backgrounds are eligible and will be encouraged to enroll. However we do not expect differences based on ethnicity, and this small study will not therefore be powered to make conclusions about ethnic differences in induction of GR-regulated genes with dexamethasone.
研究组 & 干预措施
Dexamethasone
20 mg of dexamethasone
干预措施: Dexamethasone (Drug)
Placebo [Saline]
Saline
干预措施: Placebo (Drug)
结局指标
主要结局
Increase in SGK1 mRNA Expression Level
时间窗: >= 30 min
Increase in SGK1 mRNA expression level is calculated as fold change = post / pre
Increase in MKP1/DuSP1 mRNA Expression Level
时间窗: >= 30 min
Increase in MKP1/DuSP1 mRNA expression level is calculated as fold change = post / pre
次要结局
未报告次要终点