Screening for Subjects to Participate in Studies of Blood Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00695123|
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : April 8, 2021
This study will determine eligibility for participation in research studies on blood disorders conducted by the National Heart, Lung and Blood Institute and the National Institute of Diabetes, Digestive, and Kidney Diseases.
Healthy volunteers, patients with blood disorders under study by NHLBI and NIDDK and potential stem cell donors for patients with blood disorders who are 8 years of age and older may be eligible for this screening protocol. (Healthy volunteers who qualify for research protocols would serve as control subjects.)
Participants undergo the following tests and procedures:
- Medical history, physical examination, blood tests and urine sample collection.
- Buccal mucosa sample collection. (Cells are collected from the inside of the cheek by gentle scraping with a bristly brush.)
- Bone marrow aspiration (only for volunteers 18 years of age and older).
Potential Stem Cell Donor
-Same as for healthy volunteers plus evaluations that may include electrocardiogram, echocardiogram, imaging studies (X-rays, CT scans, MRI scans and others), heart evaluation, and lung function tests.
Patient with Blood Disorder
- Same as for stem cell donors plus additional evaluations and treatments that may include radiation oncology evaluation, catheter placement, blood transfusions, kidney and liver biopsies. Short courses of drug treatment for induction of fetal hemoglobin in sickle cell patients, and/or iron chelation in patients receiving chronic red cell transfusions may be included as well.
|Condition or disease|
|Bone Marrow Transplant Sickle Cell Disease G-CSF|
|Study Type :||Observational|
|Actual Enrollment :||816 participants|
|Official Title:||Screening of Subjects to Determine Eligibility to Safely Participate in Blood Disorders Studies|
|Actual Study Start Date :||July 3, 2008|
|Actual Primary Completion Date :||April 2, 2021|
|Actual Study Completion Date :||April 2, 2021|
Only 1 participant group (cohort)
The subject may have a blood disorder, may be a stem cell transplant donor, or may be a healthy volunteer.
- Evaluate consented subjects with blood disorders [ Time Frame: ongoing ]1) to assess the hematologic problems, the status of other organ systems, and their ability to safely tolerate active treatment protocols; 2) to determine eligibility for active MMB and/or MCHB protocols. Subjects may require screening procedures and clinical treatments in order to determine eligibility for participation; and 3) to allow time for counseling and deliberation regarding best treatment option
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): NCT00695123
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Matthew M Hsieh, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|