NCT00090662 Collection of Data and Samples From Healthy Donors for Use in Translational Research
| NCT ID | NCT00090662 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Healthy Volunteer |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2004-12-09 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 250 participants in total. It began in 2004-12-09.
⚠ 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
Increased numbers of white blood cells called eosinophils can cause disease. To investigate this disease, researchers need blood, urine, sputum, stool, cerebrospinal fluid, skin and/or bone marrow samples to compare to samples from patients with this problem. Some of the samples will be used for genetic testing or future research. This study will last for about 10 years and will include a maximum of 50 paid volunteers ages 18 to 65.
Eligibility Criteria
* Eligibility criteria for volunteer whole blood donation are based on the Standards of the AABB and the Code of Federal Regulation 21 CFR 640. 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
Contact & Investigator
Amy D Klion, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Frequently Asked Questions
Who can join the NCT00090662 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00090662 currently recruiting?
Yes, NCT00090662 is actively recruiting participants. Contact the research team at browntw@mail.nih.gov for enrollment information.
Where is the NCT00090662 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT00090662 clinical trial?
NCT00090662 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 250 participants.