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Protocol Number:
08-H-0156
- Title:
Screening of Subjects to Determine Eligibility to Safely Participate in Blood Disorders Studies
- Number:
08-H-0156
- Summary:
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:
Healthy Volunteers
-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.
- Sponsoring Institute:
-
National Heart, Lung and Blood Institute (NHLBI)
- Recruitment Detail
- Type:
Participants currently recruited/enrolled
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
None
- Eligibility Criteria:
INCLUSION CRITERIA:
Patients able to give informed consent, and may have a blood disorder, may be a stem cell transplant donor, or may be a healthy volunteer.
The subject, age greater than or equal to 8, has a reasonable likelihood of having a disorder for which the Molecular Medicine Branch or Molecular and Clinical Hematology Branch has an active research protocol, and based on information received from an outside physician, he/she appears to meet at least preliminary eligibility criteria for that protocol
The subject, age greater than or equal to 8, is a donor for a subject for whom the Molecular Medicine Branch or the Molecular and Clinical Hematology Branch has an active stem cell transplant protocol and based on information received from an outside physician, he/she appears to meet preliminary eligibility as a donor
The subject, age greater than or equal to 18, is a healthy volunteer for whom the Molecular Medicine Branch or the Molecular and Clinical Hematology Branch has an active study recruiting healthy normal volunteers and he/she appears to meet preliminary eligibility as a normal volunteer.
EXCLUSION CRITERIA:
Unable to comprehend the investigational nature of the protocol participation.
Abnormal CBC for healthy volunteers.
Positive pregnancy test for stem cell donors and healthy volunteers.
- Special Instructions:
Currently Not Provided
- Keywords:
-
Bone Marrow Transplant
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Sickle Cell Disease
-
G-CSF
-
Apheresis
- Recruitment Keyword(s):
-
Bone Marrow Transplant
-
Sickle Cell Disease
-
SD
-
Healthy Volunteer
-
HV
- Condition(s):
-
Bone Marrow Transplant
-
Sickle Cell Disease
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Intervention(s):
- None
- Supporting Site:
- National Institute of Diabetes and Digestive and Kidney Diseases
- Contact(s):
-
Patient Recruitment and Public Liaison Office
Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 Electronic Mail:prpl@mail.cc.nih.gov
- Citation(s):
Not Provided
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008
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