NCT04569773进行中（未招募）不适用
Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 16
- 主要终点
- Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer
研究概览
简要总结
The purpose of this study is to learn more about the factors that influence decision-making before surgery (distress about cancer and/or reproductive concerns) and the possibility of regret after surgery.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 and ≤ 50 years
- •Premenopausal
- •Endometrioid histological diagnosis
- •Scheduled for surgical intervention at MSKCC
- •FIGO grade 1-2, clinical stage I
- •Disease confined to uterus, no clear evidence of deep (≥50%) myoinvasion on imaging (MRI preferred, ultrasound optional)
- •Normal ovaries on preoperative imaging
- •Able to provide informed consent
- •English-speaking
排除标准
- •Known Lynch syndrome
- •Prior bilateral oophorectomy
- •Personal history of hormone receptor-positive breast carcinoma
- •Increased risk of ovarian cancer identified on the basis of family or personal history
- •Women currently on hormonal contraception, letrozole, or tamoxifen may not opt-in to AMH
- •Women who recently underwent ovarian stimulation within the past 3 months may not opt-in to AMH
- •Women who have pituitary dysfunction (or any pituitary disorders) may not opt-in to AMH
- •Women who completed chemotherapy within <12 months may not opt-in to AMH
结局指标
主要结局
Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer
时间窗: Up to 12 months post-operatively
Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer to identify influencing factors-in particular, cancer-related psychological distress and reproductive concerns-and any potential decisional regrets following surgical intervention.
次要结局
未报告次要终点
研究者
研究点 (16)
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