NCT00091871 A Longitudinal Study of Familial Hypereosinophilia (FE): Natural History and Markers of Disease Progression
| NCT ID | NCT00091871 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Eosinophilia |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2005-06-08 |
| 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 50 participants in total. It began in 2005-06-08.
⚠ 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
Eosinophils are a type of white blood cell. Elevated eosinophil levels can damage the heart, nerves, and other organs, in the syndrome known as hypereosinophilic syndrome (HES). Some individuals have a hereditary form of HES known as familial eosinophilia (FE). More research on the causation and mechanisms of HES is needed in order to design more effective and less toxic therapies. This study will investigate FE and its genetic causes, damage mechanisms, and disease markers (such as blood test abnormalities). It will enroll approximately 50 individuals (both adults and children) from a previously studied family with FE. This is a long-term study of indefinite duration. Participants will undergo yearly clinical examinations including medical history, physical examination, bloodwork, EKG, echocardiogram, and pulmonary function tests, with additional or more frequent examinations and tests as required. In addition, participants will donate blood and tissue for research purposes. Both adult and child participants will donate blood. At the initial evaluation, adult participants will donate bone marrow. During the study, some adult participants will also undergo a limited number of leukaopheresis sessions, in which blood is donated from one arm, the blood is separated into red blood cells and other components, and the red blood cells are returned into the donor's other arm. ...
Eligibility Criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 1-100 years of age * Genetically related member of a previously identified family with FE * Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Any condition that the investigator feels put the subject at unacceptable risk for participation in the study * Pregnancy (in family members who do not have eosinophilia)
Contact & Investigator
Amy D Klion, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Frequently Asked Questions
Who can join the NCT00091871 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 100 Years, studying Eosinophilia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00091871 currently recruiting?
Yes, NCT00091871 is actively recruiting participants. Contact the research team at browntw@mail.nih.gov for enrollment information.
Where is the NCT00091871 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT00091871 clinical trial?
NCT00091871 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 50 participants.