跳至主要内容
临床试验/NCT05203562
NCT05203562Unknown2 期

The Prophylactic Role of Aromatase Inhibitor Letrozole in Decreasing the Incidence of Gestational Trophoblastic Neoplasia in Patients With Complete Hydatidiform Mole

Zagazig University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
200
试验地点
1
主要终点
(β-hCG) level

研究概览

简要总结

Prophylactic use of aromatase inhibitor is effective in decreasing the incidence of Gestational Trophoblastic Neoplasia (GTN) in patients with complete hydatidiform mole (CHM)

详细描述

Management of hydatidiform mole is usually evacuation followed by β-hcg surveillance to early detect cases of GTN . The risk of developing GTN is reported to be 16% to 20% in women with CHM . GTN is a potentially life-threatening malignancy but has an excellent cure rate. Trials were conducted to assess the role of prophylactic chemotherapy to prevent the development of GTN. In addition to their side effects, a meta-analysis concluded that there is insufficient evidence to support the use of prophylactic chemotherapy in clinical practice. Third-generation aromatase inhibitors such as letrozole have been shown to successfully block estrogen production in women of reproductive age. Their safety, high tolerability, low cost, and associated minimal adverse effects have all been established over several decades of clinical use and recently used successfully alone in the medical treatment of ectopic pregnancy making marked degenerative effects on the placenta.

The study hypothesizes that by inhibiting the estrogen synthetase (the aromatase enzyme) progesterone would not exert its physiological role in maintaining early pregnancy including complete hydatidiform mole. Thus, using a prophylactic aromatase inhibitor after CHM may have a role in the prevention of GTN and more effective clearance of β-hcg.

Rational GTN is a potentially life-threatening malignancy. The risk of progression of CHM to GTN is 20%. Prophylactic use of aromatase inhibitor may decrease the incidence of GTN.

Research question:

Is prophylactic use of aromatase inhibitor effective in decreasing the incidence of GTN in patients with CHM

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women were diagnosed to have CHM by ultrasound and confirmed by histopathological examination

排除标准

  • Metastatic disease associated with HM at presentation, in which situation chemotherapy, rather than prophylactic treatment, as prescribed,
  • Late diagnosis of CHM made only by histological examination of curetted material
  • Uterine evacuation at another hospital and patient seen at the optimum patient care only for follow up

研究组 & 干预措施

Prophylactic letrozole group II

Experimental

Patients with complete mole treated by evacuation of using suction curettage followed by 5mg daily letrozole for 10 days followed by conservative follow up

干预措施: Suction evacuation (Procedure)

Control group I

Active Comparator

Patients with complete mole treated by evacuation of using suction curettage followed by conservative follow up

干预措施: Suction evacuation (Procedure)

Prophylactic letrozole group II

Experimental

Patients with complete mole treated by evacuation of using suction curettage followed by 5mg daily letrozole for 10 days followed by conservative follow up

干预措施: Letrozole tablets (Drug)

结局指标

主要结局

(β-hCG) level

时间窗: Six months after evacuation

A quantitative human chorionic gonadotropin

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohamed Ali Alabiad, MD

Principal Investigator

Zagazig University

研究点 (1)

Loading locations...

相似试验