Protocol Details

Eosinophil Activation and Function in Parasitic Infections and Other Conditions with Increased Tissue or Peripheral Blood Eosinophilia in Humans

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	94-I-0079
Sponsoring Institute	National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 1 Max Age: 100
Referral Letter Required	Yes
Population Exclusion(s)	None
Special Instructions	Currently Not Provided
Keywords	Eosinophils; Helminth Parasites; Hypereosinophilia; Allergy; Asthma
Recruitment Keyword(s)	None
Condition(s)	Asthma; Eosinophilia; Helminthiasis; Hypersensitivity; Parasitic Disease
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Institute of Allergy and Infectious Diseases

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:

- Annual Follow-up evaluations - Physical examinations and blood tests to evaluate changes in the patient's condition and eosinophil counts over time.

- Bone marrow biopsy and aspiration will be recommended during the initial evaluation, and in certain patients at other times when it is important to look directly at the newly developing cells in the bone marrow. For this procedure an area of skin and bone is anesthetized with xylocaine (an anesthetic similar to that used by dentists), and a very sharp needle is used to sample the bone marrow for evaluation. Bone marrow biopsy and aspiration can have side effects of pain and/or bleeding into the skin and soft tissues at the site of the procedure. Rarely the area at the biopsy site can become infected, and is treated with antibiotics.

- Genetic testing: Some of the blood drawn from you as part of this study will be used for genetic tests. Genetic tests can help researchers study how health or illness is passed on to you by your parents or from you to your children. Any genetic information collected or discovered about you or your family will be confidential.

- Leukapheresis (only patients 18 years and older) to collect large numbers of certain cells - In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are then removed and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm.

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Eligibility

ELIGIBILITY CRITERIA (EOSINOPHILIC SUBJECTS):

INCLUSION CRITERIA:

1) 1-100 years of age

2) documented peripheral blood eosinophil count > 1500/mm3 or tissue eosinophilia (abnormal accumulation of eosinophils in the skin or other body tissues)

3) has a primary (non-NIH) physician for routine medical care

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:

1) 1-100 years of age

2) extended family member of a study participant in 94-I-0079

EXCLUSION CRITERIA:

1) any condition that the investigator feels put the subject at unacceptable risk for participation in the study.

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Citations:

Adhesion molecules in cell interactions

Cell adhesion in the immune system

Analysis of lymphocyte activation and metabolism by flow cytometry

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Contacts:

Principal Investigator	Referral Contact	For more information http://clinicalstudies.info.nih.gov.
Amy D. Klion, M.D. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health Building 10 Room 5-3750 10 Center Drive Bethesda, Maryland 20892 (301) 480-6916 hmalech@niaid.nih.gov	Amy D. Klion, M.D. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health Building 10 Room 6-3750 10 Center Drive Bethesda, Maryland 20892 (301) 402-1773 maxwells@niaid.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:

NCT00001406

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