Desmoid Tumor and Pregnancy: Effect of Pregnancy on Disease Control and Effect of Diagnosis on Pregnancy History. An International Multicenter Retrospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 7
- 主要终点
- Local recurrence
研究概览
简要总结
Desmoid tumors (DT) are rare disease of intermediate malignancy with variable and often unpredictable clinical course. There is a growing interest in defining potential risk of recurrence or progression during or after pregnancy and in identifying potential obstetrical risks and infertility rate of desmoid patients.
Aim of the study:
- to define the impact of pregnancy on diagnosis, progression and recurrence of DT;
- to define the risks related to DT of obstetrical risks and decisions to interrupt or avoid pregnancy after the diagnosis of DT.
详细描述
Background. Desmoid tumors (DT) are rare disease of intermediate malignancy with variable and often unpredictable clinical course.
A significant proportion of female patients with a diagnosis of DT have a recent pregnancy history and on the contrary, the diagnosis of DT is often made during gestation or shortly thereafter. Understanding the behavior of desmoids during or after pregnancy is crucial to define the safest management of the tumor itself and of the pregnancy.
Moreover, analyzing the impact of DT on decisions regarding the pregnancy (and in turn fertility), we will be able to implement new tools assisting and counselling women with DT.
Aim of the study.
- to define the management of DT in patients diagnosed with desmoid before pregnancy and during pregnancy;
- analyze the oncological outcome of desmoid patients during and after pregnancy;
- assess potential obstetrical risks and decisions to interrupt or avoid pregnancy after the diagnosis of DT
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically-proven DT;
- •female patients
- •fertile age, >18 years;
- •concomitant or subsequent pregnancy (study group), or no history of pregnancy (screening group).
排除标准
- •suspected DT without histological diagnosis • male patients affected by DT
- •<18 years old, and non-fertile age.
结局指标
主要结局
Local recurrence
时间窗: January 2000- December 2020
Local recurrence detected during pregnancy or within 1 year after delivery
Proportion of new disease progression during pregnancy Progression disease according to RECIST within 1 year after delivery in patients with previous stable disease. Proportion of new disease progression during pregnancy
时间窗: January 2000- December 2020
Progression disease according to RECIST within 1 year after delivery in patients with previous stable disease.
次要结局
- Rate of spontaneous and induced abortion(January 2000- December 2020)
- Rate of obstetric and delivery complications(January 2000- December 2020)
- Spontaneous regression(January 2000- December 2020)
- Proportion of patients shifting from active surveillance/no treatment to active treatment(January 2000- December 2020)
- Time to progression(January 2000- December 2020)