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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Year to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Physical exams, Biopsies, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All participants will have a thorough medical history, physical examination and blood tests."
  • "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."
  • "Creation of a patient-related outcomes questionnaire for use in future treatment studies of HES Exploratory Endpoints: 1."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how and why eosinophils, a type of white blood cell, become active and affect the body's defenses. It is for people ages 1–100 with high levels of these cells or possible organ problems linked to them, and their extended family members. It does not test new treatments.

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....

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 1–100 years old.
  • Be willing to follow all study steps and be available for the full study.
  • You or your legal representative must be able to understand and sign the consent form.
  • Patients: Have a recorded blood eosinophil count above 1,500/mm³, a buildup of these cells in skin or other tissues, or suspected organ problems caused by them.
  • Patients: Have a doctor outside the National Institutes of Health (NIH) for regular medical care.
  • Relatives: Be an extended family member of a patient taking part in this study.

Who can't join

  • Have a physical or mental health condition that the study doctor thinks would prevent you from taking part.
  • Relatives: Be pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MD