NCT02226302已完成不适用
Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
Queensland Centre for Gynaecological Cancer2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Identify estrogen-response genes in endometrial cancer
研究概览
简要总结
The objective is to develop an organotypic model to assess the effects of obesity on the expression and methylation status of estrogen-responsive genes in endometrial cancer. Omental fat samples will be removed from participants during surgery and these fat samples will be used in laboratory analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-80 years
- •Any patient having abdominal surgery (Laparoscopic or open technique) for benign conditions
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Patients must have adequate:
- •Hematologic function: Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L
- •Renal function: serum creatinine ≤ ULN or estimated glomerular filtration rate (eGFR) [CKD-EPI Formula] ≥ 60 mL/min
- •Hepatic function: serum bilirubin ≤ 1.5 x ULN and AST ≤ 2.5 x ULN and ALT≤ 2.5 x ULN
- •Physically able to undergo surgery
- •Written informed consent
排除标准
- •Confirmed gynaecological malignancy
- •Contraindications and/or unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
- •Patients who are pregnant or lactating
- •Serious illness or medical condition but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (patients with stable AF are eligible), or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients with disseminated intra-peritoneal malignancy or suspected ovarian cancer
- •HIV positive
- •Previous bariatric surgery
结局指标
主要结局
Identify estrogen-response genes in endometrial cancer
时间窗: Baseline
Omental fat will be collected from 6 lean patients, 6 obese patients and 4 controls (male patients) and co-cultured with endometrial cancer cell lines
次要结局
- Examine how expression of estrogen response genes are altered in obesity(Baseline)
研究者
研究点 (2)
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