Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Near-Infrared Spectroscopy (NIRS)
研究概览
简要总结
SURVIVORS
Study participants are being asked to take part in this research study called HODNIRS because the participant is a survivor of Hodgkin Lymphoma (HL) treated with chest radiation and bleomycin at St. Jude Children's Research Hospital. The study is being done to help investigators understand the link between long term effects of chest radiation and bleomycin for HL and brain function in survivors.
Primary Objective To evaluate dynamic changes in CBF and oxygenation during exercise with Near Infrared Spectroscopy (NIRS) in HL survivors and non-cancer controls matched for age, sex, race, and ethnicity. .
Secondary Objectives To examine the degree of CO2 clearance (DLCO/ETCO2) during rest and exercise in Hodgkin Lymphoma (HL) survivors compared to non-cancer controls matched for age, sex, race, and ethnicity.
CONTROLS
Volunteers are being asked to take part in this research study because they are non-first degree relative or friend of someone who received treatment for a childhood cancer or similar illness at St. Jude Children's Research Hospital or are an employee/affiliate of St. Jude Children's Research Hospital and have agreed to be a St. Jude Life Cohort Study (SJLIFE) community control.
详细描述
NIRS is a portable, non-invasive, brain imaging device that uses low levels of non-ionizing light to record variations in blood flow in the brain. The NIRS is wearable and can read blood flow to the brain during physical activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HL Survivors
- •Completed bleomycin and/or thoracic radiation therapy for HL at SJCRH.
- •<21-years old at diagnosis; currently ≥18-years of age and ≥2-years post therapy.
- •SJLIFE or ACT/SJLIFE participants
- •English language proficiency.
- •Community Controls
- •SJLIFE control.
- •≥18-years of age at the time of enrollment with age sampling to broadly match the HL survivors.
排除标准
- •HL Survivors
- •History of cranial or total-body irradiation therapy.
- •History of intrathecal or high dose intravenous antimetabolite therapy.
- •History of head injury or diagnosis of a genetic disorder associated with cognitive impairment.
研究组 & 干预措施
SURVIVOR
A survivor of Hodgkin Lymphoma (HL) treated with chest radiation and bleomycin at St. Jude Children's Research Hospital.
and Control: Voluntarily taking part in this study because you are a relative, friend or employee of St. Jude Children's Research Hospital.
干预措施: Near Infrared Spectroscopy (NIRS) (Device)
结局指标
主要结局
Near-Infrared Spectroscopy (NIRS)
时间窗: Baseline
a non-invasive imaging technology that is used to measure regional or global cerebral tissue oxygenation and cerebral blood flow (CBF) during exercise. NIRS takes advantage of the fact that oxygenated blood and de-oxygenated blood absorb light differently. By measuring the reflected light from blood, the concentration of both oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (HbdO2) using the modified Beer-Lambert Law can be calculated.
次要结局
- Cardiopulmonary Exercise Testing (CPX)(Baseline)
- Pulmonary Function Testing(Baseline)
- Neurocognitive Outcomes(Baseline)
- Cardiopulmonary Exercise Testing (CPX)(Baseline)
- Pulmonary Function Testing(Baseline)
- Neurocognitive Outcomes(Baseline)