Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001406
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
1999-11-03
Brief Title:
Activation and Function of Eosinophils in Conditions With Blood or Tissue Eosinophilia
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Eosinophil Activation and Function in Parasitic Infections and Other Conditions With Increased Tissue or Peripheral Blood Eosinophilia in Humans
Status:
RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 750ml 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 persons 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 patients 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 andor 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
Patients 1 to 100 years of age with eosinophil counts greater than 750ml 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 persons 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 patients 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 andor 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
Detailed Description:
Study Description This study is designed to collect data and clinical samples from participants with elevated eosinophil counts in the peripheral blood or tissues or their relatives to enhance our understanding of the mechanisms driving eosinophilia and eosinophil activation in patients with a wide range of eosinophilic disorders with the ultimate goal of improving diagnostics and identifying novel treatment modalities for these patients Eosinophilic participants will undergo an extensive clinical evaluation at baseline and at least yearly thereafter focused on the identification of the cause of eosinophilia and the presence of end organ manifestations Blood bone marrow tissue andor body fluids will be collected for research purposes at initial and follow-up visits to address broader questions relating to the varied etiologies of eosinophilia biomarkers of disease activity and eosinophil activation and the functional role of eosinophils in homeostasis and disease pathogenesis While this protocol is not primarily designed to study treatment of eosinophilic patients the clinical and immunological responses to therapy will be monitored This protocol will also allow clinical and laboratory evaluation of family members of subjects with eosinophilia to help identify genetic causes of eosinophilia and to provide controls for immunologic studies
Objectives Primary Objective to understand the mechanisms driving eosinophilia and eosinophil activation in patients with a 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 effects of eosinophilia in patients with HES
3 To assess the effects of race sex ethnicity and environmental factors on the prevalence and clinical manifestations of eosinophilic disorders
Endpoints
Primary Endpoint
Identification and characterization of clinical and genetic variants of hypereosinophilic syndromes HES
Secondary Endpoints
1 Identification of laboratory and clinical tests that distinguish between clinical and genetic variants of HES
2a Identification of biomarkers of disease activity and specific organ involvement in eosinophilic disorders
2b Identification of new therapeutic targets for the treatment of HES
3 Delineation of the effects of therapeutic agents on eosinophil development activation recruitment to tissues andor apoptosis
4 Creation of a patient-related outcomes questionnaire for use in future treatment studies of HES
Exploratory Endpoints
1 Description of the consequences of eosinophilia andor eosinophil depletion in the context of varied immunologic and inflammatory
settings
2 Collection of standardized longitudinal data on disease activity and outcome in patients with hypereosinophilia
3 Comparison of prevalence and clinical manifestations of eosinophilic disorders among varied subpopulations of patients
Objectives Primary Objective to understand the mechanisms driving eosinophilia and eosinophil activation in patients with a 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 effects of eosinophilia in patients with HES
3 To assess the effects of race sex ethnicity and environmental factors on the prevalence and clinical manifestations of eosinophilic disorders
Endpoints
Primary Endpoint
Identification and characterization of clinical and genetic variants of hypereosinophilic syndromes HES
Secondary Endpoints
1 Identification of laboratory and clinical tests that distinguish between clinical and genetic variants of HES
2a Identification of biomarkers of disease activity and specific organ involvement in eosinophilic disorders
2b Identification of new therapeutic targets for the treatment of HES
3 Delineation of the effects of therapeutic agents on eosinophil development activation recruitment to tissues andor apoptosis
4 Creation of a patient-related outcomes questionnaire for use in future treatment studies of HES
Exploratory Endpoints
1 Description of the consequences of eosinophilia andor eosinophil depletion in the context of varied immunologic and inflammatory
settings
2 Collection of standardized longitudinal data on disease activity and outcome in patients with hypereosinophilia
3 Comparison of prevalence and clinical manifestations of eosinophilic disorders among varied subpopulations of patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 94-I-0079 | None | None | None |