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| ID | Type | Description | Link |
|---|---|---|---|
| 03-H-0051 |
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This study will collect samples of blood, stool, bone marrow, or other tissues from patients with hepatitis-associated aplastic anemia to investigate a possible association between exposure to viruses and the development of aplastic anemia in these patients. Cells from the samples obtained may be grown in the laboratory for future studies. Patients samples may be used to:
Patients 2 years of age and older with severe aplastic anemia that developed within 6 months of an episode of hepatitis may be eligible for this study.
Participants will complete questionnaires and provide tissue samples as described below.
Questionnaires
All patients (or another respondent for the patient) will fill out a questionnaire including demographic information (age, gender, race, ethnic group, education level, state of residence), current symptoms, medications, medical history, and history of possible exposures to toxins or viruses. A second questionnaire, which includes questions related to mental health, sexual behavior, alcohol and drug use, is optional for participants age 21 and older. These questionnaires are designed to uncover features of hepatitis-associated aplastic anemia and possibly reveal a common cause of the disease.
Sample Collections
Liver- tissue may be biopsied as part of the patient s general medical care or for NIH patients, as part of their enrollment in a treatment protocol.
Our laboratory has a long-standing interest in viruses that affect the bone marrow, especially those causing bone marrow failure. One specific syndrome, hepatitis-associated aplastic anemia, suggests that the same agent is responsible for the severe and sometimes fulminate hepatitis as well as the profound bone marrow failure. This study is designed to collect clinical data, and samples from patients with hepatitis-associated aplastic anemia, in order to learn more about the clinical features of the disease, as well as to collect blood, liver, bone marrow and stool samples where possible for ongoing virological studies. For liver and bone marrow samples, material will only be obtained when the liver or bone marrow are biopsied for other medical indications, or during the removal of the liver at the time of transplantation. No additional risk to the patient should result from either procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatitis A + AA cohort | Subjects seen either at Clinical center or by outside physician |
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| Measure | Description | Time Frame |
|---|---|---|
| to characterize hepatitis disease in subjects with aplastic anemia | To characterize hepatitis disease in subjects with aplastic anemia | Indefinite |
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Presumptive clinical diagnosis of hepatitis-associated aplastic anemia. That is, aplastic anemia within 12 months of an episode of hepatitis
Age equal to or greater than 2 years old
Ability to comprehend the investigational nature of the study and provide informed consent.
EXCLUSION CRITERIA
Suspected cholestatic or obstructed liver disease
Current diagnosis or past history of myelodysplastic syndrome, Fanconi s anemia, dyskeratosis congenita or other congenital forms of aplastic anemia.
Diagnosis of Diamond-Blackfan anemia or a constitutional marrow failure disease.
Underlying carcinoma, recent history of radiation or chemotherapy
Age less than 2 years old
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primary clinical
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| Name | Affiliation | Role |
|---|---|---|
| Neal S Young, M.D. | National Heart, Lung, and Blood Institute (NHLBI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 5081070 | Background | Bottiger LE, Westerholm B. Aplastic anaemia. 3. Aplastic anaemia and infectious hepatitis. Acta Med Scand. 1972 Oct;192(4):323-6. No abstract available. | |
| 2183887 | Background | Mary JY, Baumelou E, Guiguet M. Epidemiology of aplastic anemia in France: a prospective multicentric study. The French Cooperative Group for Epidemiological Study of Aplastic Anemia. Blood. 1990 Apr 15;75(8):1646-53. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Term |
|---|---|
| D000080983 | Bone Marrow Failure Disorders |
| D006505 | Hepatitis |
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008107 | Liver Diseases |
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| 3942690 | Background | Young NS, Issaragrasil S, Chieh CW, Takaku F. Aplastic anaemia in the Orient. Br J Haematol. 1986 Jan;62(1):1-6. doi: 10.1111/j.1365-2141.1986.tb02893.x. No abstract available. |
| D004066 |
| Digestive System Diseases |
| D000740 | Anemia |