Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
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|ClinicalTrials.gov Identifier: NCT00106925|
Recruitment Status : Recruiting
First Posted : April 1, 2005
Last Update Posted : April 21, 2021
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:
- Periodic physical examinations, eye examinations, and blood and urine tests.
- 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of the hipbone is numbed, a thin needle is inserted through the skin into the bone, and a small amount of marrow is withdrawn.
- 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.
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.
- 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.
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.
|Condition or disease|
|Graft vs Leukemia Graft vs Host Disease Graft Rejection|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Long-Term Evaluation and Follow Up Care of Patients Treated With Allogeneic Stem Cell Transplants|
|Actual Study Start Date :||April 22, 2005|
Donors (when applicable) will be co accrued to this protocol once they have survived a minimum of three years from date of transplant.
Patients (when applicable) will be co accrued to this protocol once they have survived a minimum of three years from date of transplant.
- Assure consistency of care over time for transplant patients such that outcome data can be meaningfully accrued. [ Time Frame: Ongoing ]monitor late effects of treatment and provide or recommend appropriate management
- Monitor the late effects of treatment and provide or recommend appropriate management [ Time Frame: Ongoing ]
- Describe natural history of the primary disease process. Provide fellowship training in Hematology and Oncology. [ Time Frame: Ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106925
|Contact: Kristen E Wood (Gunn), R.N.||(301) email@example.com|
|Contact: Richard W Childs, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Richard W Childs, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|