Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00001406 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Activation and Function of Eosinophils in Conditions With Blood or Tissue Eosinophilia

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 400 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Minor

    Re-verified, no change to tracked fields

  3. Minor

    Eligibility criteria expanded, about 9 words

    Secondary endpoints: details revised at 1 of 4 entries; Study description expanded, about 10 words; Publications: details revised at 7 of 7 entries

    Show what changed: 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 (LA [...] itten informed consent document Eosinophilic Patients only: 4. Documented peripheral blood count \>1500/mm3, tissue eosinophilia (abnormal accumulation of eos [...] dy tissues) or suspected eosinophilic end organ involvement 5. Primary (non-NIH) physician for routine medical care Relati [...] [...]
    Show what changed: Study description
    [...] wide range of eosinophilic disorders Secondary Objectives: 1. To develop a diagnostic algorithm that accurately classifies eosinophilic patients by underlying etiology 2. To determine the mechanisms underlying eosinophil activation and recruitment to the blood and tissues 3. To understand the mechanisms of action of therapeutic agents used or in development for the treatment of HES 4. To assess the signs and symptoms experienced by patients with HES Exploratory Objectives: 1. To investigate the multifunctional role of eosinophils in settings other than HES 2. To understand the long-term effec [...] [...]

  4. Minor

    47 amendments

    47 re-verifications since 2025-07-31, no change to tracked fields

    v351-v397

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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....
Trial Details
NCT Number NCT00001406
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Immune System Diseases, Eosinophilia, Helminthiasis, Hypersensitivity, Parasitic Disease
Enrollment 800 participants
Start Date
Updated on ClinicalTrials.gov