Healthy VolunteerNCT00090662
Collection of Data and Samples From Healthy Donors for Use in Translational Research
An observational study of Healthy Volunteer, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2004to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read the detailed description
This protocol is designed to provide data and samples from paid volunteers for use in translational studies of eosinophilia and parasitic diseases. Donors meeting standard normal donor eligibility criteria will be recruited to undergo research procedures (infrared thermography and/or esophageal string test) and/or to donate blood, body fluid and/or tissue samples obtained using conventional techniques. The investigational nature of the studies in which their data and/or samples will be used, as well as the risks and benefits of the procedures, will be explained to all volunteers, and a signed informed consent document will be obtained. Volunteers will be compensated according to an established schedule based on the duration and discomfort of the donation. Samples provided through this protocol will be used solely for in vitro research and will be assigned a unique product number. The study investigators listed on this protocol will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the data and specimens collected in this study will be used is not the subject of this protocol and will be described in general terms only, since it involves several IRB-approved LPD protocols. Because some of these protocols require normal controls without a history of asthma or allergic disease, all subjects will undergo a standardized allergy/asthma history at enrollment. Serum immunoglobulin levels and a basic RAST panel may be performed on sera from some normal donors, and some normal donors may be asked to undergo pulmonary function testing.
- Conditions
- Healthy Volunteer
- Keywords
- Cerebrospinal Fluid, Stool, Urine, Natural History, Skin, Sputum, Healthy Volunteer, HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Healthy volunteer |
What is being measured
The primary outcome is the main question the study is designed to answer.
- To provide an IRB-approved mechanism for the collection of peripheral blood, urine, sputum, stool, cerebrospinal fluid, skin biopsy and bone marrow samples from paid, volunteer donors for use in in vitro studies.
- To provide adequate and complete informed consent to the donors of research blood samples, and to assure that the education, counseling and protection of the study subjects from research risks is performed in accordance with IRB, OHRP, and other applicable Federal regulatory standards.
Measured: 50 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2004 (estimated)
- Study start9 Dec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Amy D Klion, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090662
- Sponsor's protocol ID
- 040266
- Other IDs
- 04-I-0266
- Status last verified
- 13 Oct 2026
- First submitted
- 1 Sep 2004
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No.
Publications
Bennuru S, Kodua F, Drame PM, Dahlstrom E, Nutman TB. A Novel, Highly Sensitive Nucleic Acid Amplification Test Assay for the Diagnosis of Loiasis and its Use for Detection of Circulating Cell-Free DNA. J Infect Dis. 2023 Oct 3;228(7):936-943. doi: 10.1093/infdis/jiad186.
PubMed 37243712Stokes K, Yoon P, Makiya M, Gebreegziabher M, Holland-Thomas N, Ware J, Wetzler L, Khoury P, Klion AD. Mechanisms of glucocorticoid resistance in hypereosinophilic syndromes. Clin Exp Allergy. 2019 Dec;49(12):1598-1604. doi: 10.1111/cea.13509. Epub 2019 Oct 27.
PubMed 31657082
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Data and Samples From Healthy Donors for Use in Translational Research
- ClinicalTrials.gov ID
- NCT00090662
- Acronym / sponsor ID
- 040266
- Conditions
- Healthy Volunteer
- Keywords
- Cerebrospinal Fluid, Stool, Urine, Natural History, Skin, Sputum, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 9 Dec 2004 (actual)
- First posted
- 2 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This protocol is designed to provide data and samples from paid volunteers for use in translational studies of eosinophilia and parasitic diseases. Donors meeting standard normal donor eligibility criteria will be recruited to undergo research procedures (infrared thermography and/or esophageal string test) and/or to donate blood, body fluid and/or tissue samples obtained using conventional techniques. The investigational nature of the studies in which their data and/or samples will be used, as well as the risks and benefits of the procedures, will be explained to all volunteers, and a signed informed consent document will be obtained. Volunteers will be compensated according to an established schedule based on the duration and discomfort of the donation. Samples provided through this protocol will be used solely for in vitro research and will be assigned a unique product number. The study investigators listed on this protocol will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the data and specimens collected in this study will be used is not the subject of this protocol and will be described in general terms only, since it involves several IRB-approved LPD protocols. Because some of these protocols require normal controls without a history of asthma or allergic disease, all subjects will undergo a standardized allergy/asthma history at enrollment. Serum immunoglobulin levels and a basic RAST panel may be performed on sera from some normal donors, and some normal donors may be asked to undergo pulmonary function testing.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | – | –Healthy volunteer |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
- To provide an IRB-approved mechanism for the collection of peripheral blood, urine, sputum, stool, cerebrospinal fluid, skin biopsy and bone marrow samples from paid, volunteer donors for use in in vitro studies.
Time frame: 50 years
- To provide adequate and complete informed consent to the donors of research blood samples, and to assure that the education, counseling and protection of the study subjects from research risks is performed in accordance with IRB, OHRP, and other applicable Federal regulatory standards.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 37243712Bennuru S, Kodua F, Drame PM, Dahlstrom E, Nutman TB. A Novel, Highly Sensitive Nucleic Acid Amplification Test Assay for the Diagnosis of Loiasis and its Use for Detection of Circulating Cell-Free DNA. J Infect Dis. 2023 Oct 3;228(7):936-943. doi: 10.1093/infdis/jiad186.
- Derived from this study: PubMed 31657082Stokes K, Yoon P, Makiya M, Gebreegziabher M, Holland-Thomas N, Ware J, Wetzler L, Khoury P, Klion AD. Mechanisms of glucocorticoid resistance in hypereosinophilic syndromes. Clin Exp Allergy. 2019 Dec;49(12):1598-1604. doi: 10.1111/cea.13509. Epub 2019 Oct 27.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. No.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy D Klion, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas W Brown, R.N. ((301) 402-7823, browntw@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- To provide an IRB-approved mechanism for the collection of peripheral blood, urine, sputum, stool, cerebrospinal fluid, skin biopsy and bone marrow samples from paid, volunteer donors for use in in vitro studies. (time frame: 50 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00090662, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.