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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001406 |
Purpose
This study will investigate how, why and under what conditions eosinophils (a type of white blood cell) become activated and will examine their function in immune reactions. Eosinophil counts often rise in response to allergies, asthma, and parasitic worm infections. They can also go up in uncommon autoimmune conditions and, rarely, in association with tumors. Elevated levels of these cells is called eosinophilia. Usually, eosinophilia causes no apparent symptoms, but in rare cases there may be local swelling and itching, allergic lung problems, heart disease or nerve damage caused by the release of toxic substances in these cells into body tissues.
Patients 1 to 100 years of age with eosinophil counts greater than 750/ml or an abnormal accumulation of eosinophils in the skin or body tissues may be eligible for this study. All participants will have a thorough medical history, physical examination and blood tests. Depending on the person's age and symptoms, other diagnostic tests may be done, including specialized studies of the eye, lungs, skin, bone marrow, nerves or heart. This is not a treatment study, and no experimental treatments will be offered. Patients who require treatment will receive standard medical care.
Certain other procedures may be requested solely for research purposes. All participants will be asked to donate extra blood for laboratory studies investigating how immune cells and other immune substances in the blood act to stimulate a rise in eosinophils. In addition, some participants may undergo one or more of the following:
| Condition |
|---|
|
Asthma Eosinophilia Helminthiasis Hypersensitivity Parasitic Disease |
| Study Type: | Observational |
| Official Title: | Eosinophil Activation and Function in Parasitic Infections and Other Conditions With Increased Tissue or Peripheral Blood Eosinophilia in Humans |
| Estimated Enrollment: | 400 |
| Study Start Date: | February 1994 |
Subjects admitted on this protocol will have elevated eosinophil counts in the peripheral blood or tissues or will be relatives of subjects with eosinophilia. Eosinophilic subjects will undergo an extensive clinical evaluation focused on the identification of the cause of eosinophilia and the presence of end organ manifestations. In addition, they will be characterized in detail immunologically, and their blood cells and/or serum will be collected to provide reagents (eg. specific antibodies, T-cell clones, etc.) that will be used in the laboratory to address broader questions relating to the etiology of eosinophilia, its immunoregulation, the degree and source of eosinophil activation, and/or the functional role of eosinophils in the afferent arm of those immune response where they are prominent. While the protocol is not primarily designed to study treatment of patients with blood and tissue eosinophilia, the clinical and immunological responses to various medically indicated therapies will be carefully monitored. The subjects themselves will be followed over time to determine the kinetics and nature of the factors affecting their degree of eosinophilia and the level of activation or degranulation of the eosinophils at various time points and in response to various stimuli. It is anticipated that the subjects will receive a degree of clinical evaluation, care and monitoring more extensive than that generally available and that the specimens collected from them will prove to be valuable reagents for laboratory studies related to eosinophilia, eosinophil activation and function. Recognized causes of subjects' hypereosinophilia will be treated appropriately either by our own clinical service or by the referring physicians. Experimental chemotherapy in this protocol is restricted to that administered under special exemption status. This protocol will also allow clinical and laboratory evaluation of family members of subjects with eosinophilia in order to help identify genetic causes of eosinophila and to provide controls for immunologic studies.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
1) medical conditions or therapies that the investigator feels put the subject at unacceptable risk for participation in the study
ELIGIBILITY CRITERIA (RELATIVES):
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
1) any condition that the investigator feels put the subject at unacceptable risk for participation in the study.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact | |
More Information
| ClinicalTrials.gov Identifier: | NCT00001406 History of Changes |
| Other Study ID Numbers: | 940079, 94-I-0079 |
| Study First Received: | November 3, 1999 |
| Last Updated: | December 23, 2011 |
| Health Authority: | United States: Federal Government |
|
Eosinophils Helminth Parasites Hypereosinophilia Allergy Asthma |
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Asthma Eosinophilia Helminthiasis Hypersensitivity Parasitic Diseases Bronchial Diseases Respiratory Tract Diseases |
Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders Hematologic Diseases |
