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Investigations Regarding B-cell Subsets in Humans

This study has been terminated.
(PI is no longer in his research role at the institution)
Sponsor:
Information provided by (Responsible Party):
Daniel Griffin, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00926692
First received: June 19, 2009
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

The aim of this research is to define the human equivalent of mouse B1 cells.


Condition Intervention
Healthy
Other: Blood draw

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigations Regarding B-cell Subsets in Humans

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Presence of B-1 cells in humans [ Time Frame: determined over the years study in effect ] [ Designated as safety issue: No ]
    an equivalent cell type was isolated in humans


Enrollment: 249
Study Start Date: April 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy Subjects
All subjects are considered healthy
Other: Blood draw
Subject will have blood draw.

Detailed Description:

The specific aim of this research project is to define the human equivalent of mouse B1 cells. This will be done by evaluating IgM secretion, surface markers, functional characteristics, V gene usage, N-region addition, and phosphorylation status of intracellular proteins, gene expression, sequencing of immunoglobulin genes, determination of antigenic specificity, replication history, and response to different stimuli.

The goal of this project is to begin to the translation of decades of basic science research and research in the mouse model into the human system. It is believed that properly defining this B cell subset in humans will lead to better therapeutics, prognostics and prevention for a number of disease including infections, autoimmune disease, and cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy Control Population

Criteria

Inclusion Criteria:

  • Subject is considered by the physician to be a healthy adult.

Exclusion Criteria:

  • Subject is under the age of 18
  • Subject has an infection or is currently ill
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926692

Locations
United States, New York
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Daniel Griffin, M.D. Feinstein Institute for Medical Research
  More Information

No publications provided

Responsible Party: Daniel Griffin, Fellow Infectious Diseases, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00926692     History of Changes
Other Study ID Numbers: GCRC 0266
Study First Received: June 19, 2009
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
B-cells
CD5+
B1 Cells
Healthy Controls

ClinicalTrials.gov processed this record on November 25, 2014