Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Recruitment Rate
研究概览
简要总结
A growing population of young women with obesity are developing atypical hyperplasia (pre-cancer) and endometrial cancer. Progestin is the standard treatment for women who wish to preserve fertility, but this approach does not address the underlying cause of endometrial cancer/atypical hyperplasia (obesity); thus response rates are low and recurrence rates are high. Significant weight loss by bariatric surgery, in combination with progestin therapy may result in greater and more durable response rates.
详细描述
The incidence of endometrial cancer is increasing at an alarming rate (2.6% per year). This trend parallels the rising rate of obesity, the most significant increasing risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility and thus avoid hysterectomy are treated with progestin therapy, such as progestin intra-uterine device (pIUD). However, the pIUD achieves cancer regression in only 50-70% of women, and over 50% of initial responders will develop recurrence within two years. The effectiveness of the pIUD may be improved if the driver of endometrial cancer (obesity) was simultaneously addressed. Multiple epidemiologic studies have demonstrated that bariatric surgery reduces the risk of developing endometrial cancer. Our research aims to answer the question: "Is bariatric surgery in addition to the pIUD a feasible and acceptable option for young women with endometrial cancer/atypical hyperplasia who wish to maintain their childbearing potential compared to standard treatment of pIUD alone?
This is a pilot randomized controlled trial to assess the feasibility of a full-scale randomized controlled trial. Eligible women will be identified and consented over a 21-month period, and participants will be randomized to bariatric surgery plus standard pIUD (intervention group) or to standard pIUD alone (non-intervention group) in a 1:1 fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of grade 1 endometrioid endometrial cancer or complex atypical hyperplasia
- •Clinical stage 1 disease - no evidence of metastatic disease beyond the uterus by imaging performed (MRI, CT)
- •ECOG status <2
- •Desire for fertility preservation
- •No contraindications to progestin intrauterine device (IUD)
- •Have signed an approved informed consent form
排除标准
- •Evidence of myometrial invasion or extra-uterine disease on imaging
- •High grade or p53 endometrial cancer
- •History of other malignancies, except if curatively treated with no evidence of disease for > 5 years
- •Previous major upper abdominal surgery (ex. previous bariatric surgery, splenectomy, partial gastrectomy, liver resection, bowel resection). Appendectomy, cholecystectomy, hernia repair, and caesarean section are acceptable procedures for inclusion.
- •Current use of weight loss medication. NB: patients taking glucagon-like peptide 1 (GLP-1) agonists (e.g., OZEMPIC) for the treatment of diabetes will not be excluded.
- •Contraindications to sleeve gastrectomy
- •Medical co-morbidity with end-organ dysfunction
- •Unable to understand and participate in the informed consent process
- •Currently pregnant
- •Active smoking in ≤6 months
- •Active substance use disorder
- •Current untreated or severe psychiatric issue
结局指标
主要结局
Recruitment Rate
时间窗: Year 5
To determine the proportion of eligible women who agree to participate in the study (recruitment rate). The primary outcome will be met and a full scale randomized controlled trial to assess efficacy will be conducted if ≥ 40% recruitment rate is achieved. Patients' reasons for participation or non-participation will be recorded.
次要结局
- Completion of Bariatric Surgery(Year 5)
- Loss to Follow-Up Rate(Year 6)
- Completion of Patient Reported Outcome Questionnaires(Year 5)
- Complete Response Rate(Year 6)