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Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

Long-Term Evaluation and Follow Up Care of Patients Treated With Allogeneic Stem Cell Transplants

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
7 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Urine samples, Biopsies, Physical exams, MRI scans, X-rays, Heart tracing (ECG), Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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of the hipbone is numbed, a thin needle is inserted through the skin into the bone, and a small amount of marrow is withdrawn.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."
  • "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."
  • "Electrocardiogram (EKG) evaluates the electrical activity of the heart."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study provides long-term follow-up care for people who had a stem cell transplant from a donor at least 3 years ago. It checks how well treatment worked, whether the disease comes back, and health problems that may appear later. Visits are usually once a year.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Had your first stem cell transplant from a donor at least 3 years ago.
  • Had an experimental or standard-care donor transplant under an NHLBI study plan at NIH. Some people treated outside NIH may qualify if they have a special condition the research team wants to study.
  • Are 7 to 80 years old under the detailed eligibility rules. The study summary lists ages 10 to 80, so check with the study team.
  • Adults must understand the study and agree to take part.
  • Children must have written permission from a parent or guardian and agree to take part after the study is explained in a way they can understand.

Who can't join

  • None. Anyone who meets all the entry rules is eligible.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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

Study sites (1)

MD