接受干细胞移植治疗的患者的长期评估和随访护理
接受同种异体干细胞移植治疗的患者的长期评估和随访护理
This study will provide follow-up evaluation and care of patients who have undergone allogeneic (donor) stem cell transplantation at the NIH Clinical Center. Patients are monitored for their response to treatment, disease relapse, and later-occurring effects of the transplant.
Patients between 10 and 80 years of age who received a donor stem cell transplant at the NIH Clinical Center under an NHLBI protocol may be eligible for this study. Candidates must have had their first transplant at least 3 years before entering the current study.
Participants are generally seen in the clinic every 12 months for some or all of the following procedures:
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Periodic physical examinations, eye examinations, and blood and urine tests.
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Bone marrow aspiration and biopsy: A sample of bone marrow is obtained for microscopic examination. The patient is given local anesthesia or conscious sedation. An area of the hipbone is numbed, a thin needle is inserted through the skin into the bone, and a small amount of marrow is withdrawn.
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Tissue biopsy: A small piece of tissue or tumor is obtained for microscopic examination. Depending on the site of the biopsy, the tissue may be removed using a cookie cutter-like "punch" instrument, a needle, or a knife. The area is numbed and the tissue is removed with the appropriate tool.
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Imaging tests to visualize organs, tissues, and cellular activity in specific tissues. For these tests, the patient lies on a table that slides into the scanner. They may include the following:
- Nuclear scans use a sensitive camera to track a small amount of radioactive material (radioisotope) that is given to the patient by mouth or through a vein. The scan may show abnormal areas of tissue in the bones, liver, spleen, kidney, brain, thyroid, or spine.
- Magnetic resonance imaging (MRI) uses a magnetic field and radio waves to examine small sections of body organs and tissues.
- Computerized tomography (CT) uses x-rays and can be done from different angles to provide a 3-dimensional view of tissues and organs.
- Positron emission tomography (PET) uses a fluid with a radioisotope attached to it to show cellular activity in specific tissues. The fluid is given through a vein and travels to the cells that are most active (like cancer cells), showing if there is an actively growing tumor.
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Pulmonary (lung) function tests: The patient breathes into a machine that measures the volume of air the person can move into and out of the lungs.
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Heart function tests may include the following:
- Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.
- Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.
- Multiple gated acquisition scan (MUGA) is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.
Disease relapse or progression, or transplant-related problems may be treated with standard medical, radiation, or surgical therapy, or patients may be offered experimental therapy.
研究概览
地位
地位
详细说明
While patients surviving more than three years from SCT have a high probability of being cured of their underlying disease, they are still at risk from several categories of complications which could remain lifelong risks including late recurrence (or continued persistence) of original disease, late effects from transplant related GVHD, immune dysfunction, or consequences from the chemotherapy and/or radiation given during transplant conditioning.
Since these complications are iatrogenic, the long term follow-up of SCT patients is the ethical responsibility of the transplant team. In addition, collecting data on late occurring complications allows for prospective evaluation of the long term consequences of surviving a particular transplant treatment approach (i.e. total body irradiation versus chemotherapy conditioning, T cell depleted versus T cell replete transplants).
This protocol is designed to allow for long term evaluation, data collection, and when needed, standard medical care of patients (and when appropriate their stem cell donor) who have received allogeneic stem cell transplantation in NHLBI protocols. This may include patients with bone marrow failure states, cytopenias, hemoglobinopathies, metastatic solid tumors, or hematologic malignancies.
No investigational treatments will be administered on this protocol. Participation will not constitute a promise of long-term medical care at the NIH, nor will it provide for the evaluation and treatment of any non-transplant related medical problems. This protocol will provide access to NIH hematologists experienced in the care of post transplant patients who can help transplant patients and their local physician manage post transplant complications. In return, data collected from subjects and their donors (when applicable) will provide NIH researchers valuable information and/or laboratory samples for the purposes of better understanding the long term consequences of stem cell transplantation and identifying areas in need of future research.
研究类型
研究类型
注册 (估计的)
注册
联系人和位置
学习联系方式
学习联系方式
- 姓名:Bretagne C Cowling, R.N.
- 电话号码:(301) 827-3479
- 邮箱:bretagne.cowling@nih.gov
研究联系人备份
- 姓名:Richard W Childs, M.D.
- 电话号码:(301) 768-9433
- 邮箱:childsr@nhlbi.nih.gov
学习地点
-
-
Maryland
-
Bethesda、Maryland、美国、20892
- 招聘中
- National Institutes of Health Clinical Center
-
-
参与标准
资格标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients and donors (when applicable) will be co accrued to this protocol once they have survived a minimum of three years from date of transplant.
描述
- INCLUSION CRITERIA-TRANSPLANT RECIPIENTS:
Patients surviving three years or more from date of first stem cell transplant who have been treated.
-With an experimental allogeneic stem cell transplant on a NHLBI HB protocol
Or
-With a standard of care allogeneic stem cell transplant on an NHLBI protocol
Or
-Selectively, when the allogenic transplant was conducted outside the NIH, but the subject has a special condition of interest to the research team
Age greater than or equal to 7 years old and age less than or equal to 80
For adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian and informed assent: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.
EXCLUSION CRITERIA-STEM CELL TRANSPLANT RECIPIENTS:
None, all patients meeting the inclusion criteria will be eligible
学习计划
研究是如何设计的?
设计细节
- 观测模型:CASE_CONTROL
- 时间观点:PROSPECTIVE
团体/队列数
队列和干预
团体/队列团体/队列 |
|---|
|
1
allogeneic stem cell transplant recipients |
|
2
Donors |
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assure consistency of care over time for transplant patients such that outcome data can be meaningfully accrued.
大体时间:Ongoing
|
monitor late effects of treatment and provide or recommend appropriate management |
Ongoing
|
次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Monitor the late effects of treatment and provide or recommend appropriate management
大体时间:ongoing
|
To collect long-term follow-up data and laboratory research samples on SCT recipients to determine outcomes for particular transplant treatment approaches. |
ongoing
|
|
Describe natural history of the primary disease process. Provide fellowship training in Hematology and Oncology.
大体时间:ongoing
|
Patients will be evaluated at 4, 5 and 7 years post-transplant, then every 5 years after that to monitor the natural history of their disease, to evaluate the long term effects of transplantation, and to provide for or recommend appropriate clinical management |
ongoing
|
合作者和调查者
调查人员
调查人员
- 首席研究员:Richard W Childs, M.D.、National Heart, Lung, and Blood Institute (NHLBI)
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
学习开始
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (估计的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
与本研究相关的术语
其他研究编号
其他研究编号
- 050130
- 05-H-0130
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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