Collection of samples from healthy volunteers for research on eosinophilia
Collection of Data and Samples From Healthy Donors for Use in Translational Research
This study is looking for healthy volunteers to donate blood and tissue samples to help researchers learn more about eosinophilia and related diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00090662 on ClinicalTrials.gov |
What this trial studies
This study aims to gather data and biological samples from healthy volunteers to aid in the understanding of eosinophilia and related parasitic diseases. Participants will undergo various procedures, including blood and tissue sample donations, and may also participate in tests like infrared thermography. The collected samples will be used for in vitro research and genetic testing to compare with samples from patients with eosinophilia. The study will last approximately 10 years and will include up to 50 compensated volunteers aged 18 to 65.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals aged 18 to 65 who can provide informed consent.
Not a fit: Patients with a history of asthma or allergic diseases may not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this research could lead to better understanding and treatment options for diseases associated with eosinophilia.
How similar studies have performed: While this approach is observational and involves healthy volunteers, similar studies have successfully contributed to understanding various diseases through sample collection.
Eligibility criteria
Show full inclusion / exclusion criteria
* Eligibility criteria for volunteer whole blood donation are based on the Standards of the AABB(2) and the Code of Federal Regulation 21 CFR 640(3). Specific criteria follow: INCLUSION CRITERIA (blood, urine, stool, infrared thermograpy, photography, gastrointestinal secretion, pulmonary function testing and/or sputum donation) * ability to sign informed consent * healthy male or female * 18-85 years of age EXCLUSION CRITERIA (blood, urine, stool, infrared thermograpy, photography, gastrointestinal secretion, pulmonary function testing and/or sputum donation) * pregnancy * weight \<110 pounds * history of heart, lung, kidney disease, chronic anemia or bleeding disorders Eligibility for tissue biopsy donation (other than skin) will be determined by the protocol under which the procedure is performed and the physician performing the procedure. Eligibility criteria for volunteer bone marrow, skin and cerebrospinal fluid donation are more stringent than those for other specimen donations to minimize risk of procedure complications and maximize utility of specimens for study: INCLUSION CRITERIA (bone marrow, cerebrospinal fluid and/or skin donation) * ability to sign informed consent * healthy, male or female * 18-65 years of age * willingness to provide concurrent blood sample EXCLUSION CRITERIA (bone marrow, cerebrospinal fluid and/or skin donation) * a known bleeding disorder, low platelets (\<100k) or taking medications that interfere with blood clotting, such as aspirin, non-steroidal anti-inflammatory agents or warfarin * anemia (hemoglobin less than 12.3 mg/dL) * evidence of an immune deficiency, such as HIV infection or cancer * pregnancy * taking a medication that affects the immune response within the past month, including oral, intravenous, or injectable steroids * allergic to xylocaine * have taken an investigational drug in the last 6 months * any other medical condition that the investigator feels puts the participant at too high a risk for participation * warfarin and/or heparin treatment will not be stopped so that a subject can participate in this protocol. If warfarin or heparin was recently discontinued, a subject can be enrolled, but no bone marrow procedures will be performed until the PT is \< 15.5 seconds and the PTT is within normal range. For other agents that interfere with blood clotting without prolonging the PT, a 7- day washout period will be required before bone marrow sampling, skin biopsy or lumbar puncture. Additional exclusion criteria (cerebrospinal fluid) -Previous diagnosis of central nervous system pathology (including tumors, inflammatory conditions, infection, seizure disorder, spina bifida) * History of spinal surgery with hardware placement * History of any spinal surgery or injections of the lumbosacral spine * Headache on the day of donation Additional exclusion criteria (skin biopsy) -History of keloid or abnormal scar formation
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Amy D Klion, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Thomas W Brown, R.N.
- Email: browntw@mail.nih.gov
- Phone: (301) 402-7823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.