Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Adrenal insuffisiency prevalence
研究概览
简要总结
Allogeneic hematopoietic stem cell transplantations (allo-HSCT) is often indicated in malignant hematologic diseases. Conditioning regimens, used to reduce the tumor burden and to prevent transplant rejection, are based on chemotherapy alone or combined with total body irradiation (TBI). Endocrine complications are frequent transplant-related side effects. Investigators have been well described in children studies but less in adulthood.
The objective of this study is to assess retrospectively endocrine, bone and metabolic disorders in adult patients, 12 months after allo-HSCT.
详细描述
Patients & Methods Inclusion criteria are : patients treated with allo-HSCT from 2006 to 2016 for a malignant hematologic disease; adult and in complete remission at exploration.
Exclusion criteria are : anteriority of brain radiotherapy and prior HSCT.
Twelve months after HSCT, each patient underwent fasting measurement of IGF1, TSH, fT4, FSH, LH, sex steroids, glycemia, insulin level, and lipid profile. Unless contraindication, adrenal and growth hormone functions were assessed with insulin hypoglycemia test. A dual X-ray absorptiometry was also performed.
Investigators will assess the prevalence of endocrine, bone and metabolic disorders 12 months after allo-HSCT and describe some of their risk factors.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients treated with allo-HSCT from 2006 to 2016 for a malignant hematologic disease
- •adult and in complete remission at exploration.
排除标准
- •anteriority of brain radiotherapy
- •prior HSCT
- •pregnancy
结局指标
主要结局
Adrenal insuffisiency prevalence
时间窗: 12 month post-alloHSCT
insulin hypoglycemia test
次要结局
- Hypothyroidism prevalence(12 month post-alloHSCT)
- Growth hormon Deficiency prevalence(12 month post-alloHSCT)
- Prevalence of elevated FSH in men(12 month post-alloHSCT)
- Premature ovarian failure prevalence(12 month post-alloHSCT)
- Prevalence of low bone mineral density(12 month post-alloHSCT)
- Prevalence of obesity(12 month post-alloHSCT)
- Prevalence of hyperglycemia and insulin-resistance(12 month post-alloHSCT)
- Prevalence of dyslipidemia(12 month post-alloHSCT)