Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106925
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2005-03-31
Brief Title:
Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Long-Term Evaluation and Follow Up Care of Patients Treated With Allogeneic Stem Cell Transplants
Status:
RECRUITING
Status Verified Date:
2024-10-22
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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area of the hipbone is numbed a thin needle is inserted through the skin into the bone and a small amount of marrow is withdrawn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
1 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
2 Magnetic resonance imaging MRI uses a magnetic field and radio waves to examine small sections of body organs and tissues
3 Computerized tomography CT uses x-rays and can be done from different angles to provide a 3-dimensional view of tissues and organs
4 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
1 Electrocardiogram EKG evaluates the electrical activity of the heart Electrodes placed on the chest transmit information from the heart to a machine
2 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
3 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
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
1 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
2 Magnetic resonance imaging MRI uses a magnetic field and radio waves to examine small sections of body organs and tissues
3 Computerized tomography CT uses x-rays and can be done from different angles to provide a 3-dimensional view of tissues and organs
4 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
1 Electrocardiogram EKG evaluates the electrical activity of the heart Electrodes placed on the chest transmit information from the heart to a machine
2 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
3 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
Detailed Description:
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 andor 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 ie 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 andor laboratory samples for the purposes of better understanding the long term consequences of stem cell transplantation and identifying areas in need of future research
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 ie 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 andor laboratory samples for the purposes of better understanding the long term consequences of stem cell transplantation and identifying areas in need of future research
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-H-0130 | None | None | None |