Protocol Number: 94-I-0079

Title:

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

Number:

94-I-0079

Summary:

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 75 years of age with eosinophil counts greater than 50/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:

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

- Urine collections to look for products related to eosinophilia.

- 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.

- Bronchoalveolar lavage (only patients 18 years and older) to collect a lung tissue sample - This procedure involves inserting a catheter (flexible tube) into the lungs to instill saline (salt water) and obtain a tissue sample. This test will be done only if medically necessary.

- Skin tests to study how the body's immune system learns to react to certain allergens (extracts of things that cause allergy, such as dust, mold, trees grasses weeds, etc.). For these tests, the skin is scratched slightly and an allergen is placed over the broken skin to see if an allergic response occurs. Alternatively, a small amount of allergen is injected just under the skin with a very fine needle and the site is monitored for an allergic reaction.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

All patients 1-100 years of age with increases in blood and/or tissue eosinophilia will be eligible for evaluation under this protocol.

For bronchoalveolar lavage, only those patients 21 years old or older with acceptable pulmonary function parameters, negative sputum cultures and skin test for TB and no history of allergy to benzodiazipines, atrophine, or local anesthetic will be eligible.

No other significant medical problems such as cardiac disease or coagulopathy.

Plasmapheresis or leukapheresis will be carried out only on individuals 18 years of age or older.

Donor requirements will be similar to those for whole blood donation, with screening performed by both the investigator and the blood bank.

EXCLUSION CRITERIA:

There should be no clinical contraindications to the procedure (for example, severe anemia, cardiovascular disease, coagulopathy, etc.).

Special Instructions: Currently Not Provided

Keywords:

Eosinophils

Helminth Parasites

Hypereosinophilia

Allergy

Asthma

Cytokines

Antigen Presentation

Recruitment Keywords:

None

Conditions:

Asthma

Eosinophilia

Helminthiasis

Hypersensitivity

Parasitic Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

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

Citations:

Adhesion molecules in cell interactions

Cell adhesion in the immune system

Analysis of lymphocyte activation and metabolism by flow cytometry

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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Bethesda, Maryland 20892. Last update: 10/22/2004