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Clinical and Laboratory Investigation of Humans with Informative Iron or Erythroid Phenotypes
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
05-dk-0085 |
Sponsoring Institute |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
None |
Special Instructions |
Currently Not Provided |
Keywords |
Hemoglobin; |
Recruitment Keyword(s) |
Hemoglobin; |
Condition(s) |
Hemoglobinopathies; |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
Patients of all ages with red cell abnormalities in the following categories may be eligible for this study:
-Diseases with deficiency, overload or maldistribution of iron
-Known red blood cell diseases, such as anemias and hemoglobinopathies
-Red blood cell diseases of unknown cause, such as hemolysis of unknown cause
-Red blood cell abnormalities with no overt clinical disease, such as hereditary persistence of fetal hemoglobin
Participants undergo the following procedures:
- Medical history
- Physical examination
- Standard medical tests related to the individual's iron or red blood cell condition
Blood draw for the following purposes:
-Testing for syphilis and for the hepatitis B and C, HIV, and HTLV-1viruses, and for a pregnancy test for women who can become pregnant
-Research purposes. This blood is analyzed for genes, proteins, sugars, and fat molecules.
Eligibility
INCLUSION CRITERIA:
Group 1: Patients with known iron or erythroid diseases (examples: iron deficient anemia or ineffective erythropoiesis).
OR
Group 2: Patients with diseases of unknown etiology (example: unexplained iron overload or anemia).
OR
Group 3: Patients with an informative phenotype in the absence of overt clinical disease (example: hereditary persistence of fetal hemoglobin).
OR
Group 4: Healthy volunteers whose blood or bone marrow samples will be utilized to understand normal iron and erythroid biology and for comparison with the other groups described above.
AGE AND GENDER CONSIDERATIONS:
-Age range: Infancy to unlimited
-Adults: Adults who fall into Groups 1-4 are eligible to enroll in this protocol. They must possess the ability to comprehend the investigational nature of the study and provide informed consent.
-Minors: Written informed consent from one parent or guardian. Informed assent from minors: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend. Minors who fall into Groups 1-4 are eligible to enroll in the study for collection of research blood. Within Group 4 (healthy volunteers, minors), the research will not involve greater than minimal risk.
-Women who are pregnant or breastfeeding who fall into Groups 1-4 are eligible to enroll in this protocol. Within Group 4 (healthy volunteers, pregnant or breastfeeding), the research will not involve greater than minimal risk.
GENERAL EXCLUSION CRITERIA:
Healthy volunteers and Subjects with iron or erythroid diseases who are unable to comprehend the investigational nature of the laboratory research are ineligible to enroll in this protocol.
INCLUSION AND EXCLUSION CRITERIA FOR BONE MARROW SAMPLING:
With the exception of minors, pregnant females, and breast-feeding mothers, volunteers who meet the General Inclusion Criteria for blood collection may be offered the option of bone marrow sampling as part of this protocol. Minors, pregnant females, and breastfeeding mothers will be excluded from bone marrow sampling specifically performed for this protocol. However, they will be asked to consent for collection of up to an additional sample of bone marrow if 1) they are undergoing a bone marrow sampling procedure for clinical purposes, and 2) collection of the additional bone marrow undergoing a clinical procedure if the research sample collection doesn't alter the clinical procedure.
Other bone marrow sampling exclusion criteria include: 1) allergy to xylocaine (lidocaine) or the skin cleansing medication chlorhexidine/Hibiclens. 2) clotting disorders, low platelets (< 50,000k) or are taking medications that interfere with blood clotting, such as aspirin, non-steroidal anti-inflammatory agents (such as Motrin or Advil) or blood thinning agents (such as coumadin/warfarin).
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Jeffery L. Miller, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health BG 10 RM 9N311 10 CENTER DR BETHESDA MD 20814 (301) 402-2373 jeffm@mail.nih.gov |
Jeffery L. Miller, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health BG 10 RM 9N311 10 CENTER DR BETHESDA MD 20814 (301) 402-2373 jeffm@mail.nih.gov |
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 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00102245
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