NCT00090662

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2004

Completed
3 months until next milestone

Study Start

First participant enrolled

December 9, 2004

Completed
Last Updated

September 28, 2026

Status Verified

September 23, 2026

First QC Date

September 1, 2004

Last Update Submit

September 25, 2026

Conditions

Healthy Volunteer

Keywords

Cerebrospinal FluidStoolUrineNatural HistorySkinSputumHealthy VolunteerHV

Outcome Measures

Primary Outcomes (1)

  • - 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.

    50 years

Study Arms (1)

Healthy volunteer

Healthy volunteer

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers.

You may qualify if:

  • and/or sputum donation)
  • ability to sign informed consent
  • healthy male or female
  • years of age

You may not qualify if:

  • 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:
  • ability to sign informed consent
  • healthy male or female
  • years of age
  • willingness to provide concurrent blood sample
  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 37243712DERIVED

  • Stokes 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.

    PMID: 31657082DERIVED

Related Links

Study Officials

  • Amy D Klion, M.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas W Brown, R.N.

CONTACT

(301) 402-7823browntw@mail.nih.gov

Amy D Klion, M.D.

CONTACT

(240) 381-6073amy.klion@nih.gov

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2004

First Posted

September 2, 2004

Study Start

December 9, 2004

Last Updated

September 28, 2026

Record last verified: 2026-09-23

Data Sharing

IPD Sharing
Will not share

No.

Locations

US(1)