Health Effects After Leukemia (HEAL) Research Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Host- and treatment-related risk factors for MS
研究概览
简要总结
RATIONALE: Gathering information about metabolic syndrome from young patients who have survived acute lymphoblastic leukemia (ALL) may help doctors learn more about the disease.
PURPOSE: This phase I trial is studying the metabolic syndrome in young patients who have survived acute lymphoblastic leukemia and in healthy sibling volunteers.
详细描述
OBJECTIVES:
- Determine the prevalence of the metabolic syndrome (MS) and its component traits (i.e., obesity, hypertension, dyslipidemia, and insulin resistance) in survivors of childhood acute lymphoblastic leukemia and in healthy sibling volunteers.
- Identify host- and treatment-related risk factors for MS.
OUTLINE: This is a multicenter study.
Patients' medical charts are reviewed and patients undergo anthropometric measuring (height and weight for BMI calculation and waist and hip circumferences) and blood pressure testing. Patients also complete questionnaires on their physical activity, diet, and family history over 30-45 minutes. Blood is collected to measure cytokines (e.g., adiponectin, leptin, interleukin-6, and C-reactive protein), fasting glucose, and fasting insulin.
Healthy volunteers undergo anthropometric measuring and blood pressure testing (if they are seen in the clinic). They also complete a baseline medical history and questionnaires on their physical activity and diet.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DISEASE CHARACTERISTICS:
- •Meets one of the following eligibility criteria:
- •Childhood acute lymphoblastic leukemia survivor
- •Less than 22 years old at diagnosis
- •Treated from 1990-2007 at one of the following locations:
- •Fred Hutchinson Cancer Research Center and/or Children's Hospital and Regional Medical Center in Seattle, WA
- •Vanderbilt Children's Hospital in Nashville, TN
- •Meets 1 of the following treatment criteria:
- •Completed conventional therapy ≥ 11 months ago and in first complete remission
- •Received an allogeneic hematopoietic cell transplantation ≥ 11 months ago and in complete remission
- •No evidence of recurrent disease
- •Healthy volunteer
- •Full sibling of enrolled cancer survivor
- •Age 8-21 (if more than 1 eligible sibling, sibling of closest age is preferred)
- •No history of cancer
- •PATIENT CHARACTERISTICS:
- •Able to speak, read, and write English
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No active treatment for graft-vs-host disease
排除标准
- •Lack of ability to speak, read, and write English
- •Active treatment for graft versus host disease
结局指标
主要结局
Host- and treatment-related risk factors for MS
时间窗: 2009-2011
Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers
时间窗: 2009-2011
次要结局
未报告次要终点
研究者
Jill Simmons
Assistant Professor of Pediatrics
Vanderbilt University