Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia, A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Cardiometabolic Profile
研究概览
简要总结
This is a prospective cohort study assessing measures of cardiometabolic status, body composition, IR and GH response to stimulation after therapy in children (age 7-21 years) treated for ALL. Patients and sibling controls will be recruited from the Pediatric Hematology-Oncology Clinic at the University of Minnesota Amplatz Children's Hospital.
详细描述
This is a prospective cohort study with two groups: survivors of acute lymphoblastic leukemia (ALL) who have recently completed therapy (cases) and healthy siblings (controls) frequency matched by age and sex. Subjects in each group will have two visits. For cases, the first visit will be approximately 6 months after completion of treatment for ALL; for their siblings, the first visit occur at approximately the same time. For both cases and controls, the second visit will be 2 to 2.5 years after the first visit.
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
- 7 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 7 years to less than or equal to 21 years at time of study enrollment.
- •Acute lymphoblastic leukemia (ALL) as first cancer diagnosis and in first complete remission. Any subtype is eligible.
- •Study enrollment must take place at/after six months of completion of all chemotherapy.
- •Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or
- •Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
- •Any prior ALL therapy is allowable.
- •Age 7 years to less than or equal to 21 years at time of study enrollment.
- •Sibling of ALL patient.
排除标准
- •Diagnosis of diabetes mellitus prior to ALL diagnosis or at time of study enrollment.
- •Current pregnancy
- •Prior hematopoietic cell transplant.
- •Receiving growth hormone replacement or corticosteroids at the time of enrollment.
- •Previously diagnosed with malignancy.
- •Diagnosis of diabetes mellitus.
- •Current pregnancy
- •Receiving growth hormone replacement or corticosteroids at the time of enrollment.
结局指标
主要结局
Cardiometabolic Profile
时间窗: up to 2.5-3 Years
To determine the cardiometabolic profile (as measured by a single score based on adiposity, serum lipids, and vascular function) shortly after therapy (6 months after completion of therapy \[Visit 1\]) and again 2.5-3 yrs after completion of therapy (Visit 2) in 300 ALL patients, and compare with 200 sibling controls.
次要结局
- Prevalence of Blunted Stimulated Growth Hormone Response(Between 2.5 and 3 Years)