NCT00001406 Activation and Function of Eosinophils in Conditions With Blood or Tissue Eosinophilia
| NCT ID | NCT00001406 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Immune System Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 1997-04-21 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 1997-04-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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....
Eligibility Criteria
* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Male or female, aged 1-100 3. Ability of subject (or Legally Authorized Representative (LAR)) to understand and sign a written informed consent document Eosinophilic Patients only: 4. Documented peripheral blood count \>1500/mm3, tissue eosinophilia (abnormal accumulation of eosinophils in the skin or other body tissues) or suspected eosinophilic end organ involvement 5. Primary (non-NIH) physician for routine medical care Relatives only: 6. Extended family member of an eosinophilic participant on this protocol EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Any condition(s) or diagnosis, physical and/or psychological, that the investigator feels precludes the patient from participation in the study. Relatives only: 2. Females must not be pregnant
Contact & Investigator
Amy D Klion, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Frequently Asked Questions
Who can join the NCT00001406 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 100 Years, studying Immune System Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00001406 currently recruiting?
Yes, NCT00001406 is actively recruiting participants. Contact the research team at lpenrod@niaid.nih.gov for enrollment information.
Where is the NCT00001406 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT00001406 clinical trial?
NCT00001406 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The principal investigator is Amy D Klion, M.D. at National Institute of Allergy and Infectious Diseases (NIAID). The trial plans to enroll 800 participants.