Molecular Alterations in Human Ovarian Epithelium Induced by Chemopreventive Agents in Patients at Elevated Inherited Risk of Ovarian Cancer: A Controlled Pilot Study in Ovarian Cancer Chemoprevention
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Alteration in the histologic and molecular alterations in tissue biomarkers between patients at high risk for ovarian cancer treated with Celecoxib and treated without Celecoxib both having prophylactic oophorectomy.
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib before prophylactic oophorectomy may be an effective way to prevent the development of ovarian epithelial cancer.
PURPOSE: A controlled pilot trial to study the effectiveness of celecoxib in preventing cancer in patients at high-risk for ovarian epithelial cancer who are undergoing prophylactic oophorectomy.
详细描述
OBJECTIVES:
Primary
- Compare histologic and molecular alterations in tissue biomarkers of patients at high risk for ovarian cancer treated with celecoxib followed by prophylactic oophorectomy vs prophylactic oophorectomy only.
Secondary
- Compare alterations in gene expression pattern in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 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
Group 1
Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.
干预措施: celecoxib (Drug)
Group 1
Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.
干预措施: oophorectomy (Procedure)
Group II
Group II: Patients undergo immediate prophylactic oophorectomy.
干预措施: oophorectomy (Procedure)
结局指标
主要结局
Alteration in the histologic and molecular alterations in tissue biomarkers between patients at high risk for ovarian cancer treated with Celecoxib and treated without Celecoxib both having prophylactic oophorectomy.
时间窗: baseline (day of surgery) and 2 years
次要结局
- Alteration in gene expression between group I and group II(from baseline (surgery) to 2 years)
研究者
Edward Partridge
Principal Investigator
University of Alabama at Birmingham