Investigations Regarding B-cell Subsets in Humans | NCT00926692

Studies
Investigations Regarding B-cell Subsets in Humans

NCT00926692

Sponsor

Northwell Health

Status

Completed

Last Update Posted

Aug 26, 2015Estimated

Enrollment

249Actual

Phase

Not provided

Conditions

Healthy

Interventions

Blood draw

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jun 19, 2009

First Submission Date that Met QC Criteria

Jun 22, 2009

First Posted Date

Jun 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2015

Last Update Posted Date

Aug 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

249Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Subjects		All subjects are considered healthy	Other: Blood draw

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood draw	Other	Subject will have blood draw.	Healthy Subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of B-1 cells in humans	an equivalent cell type was isolated in humans	determined over the years study in effect

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy Control Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Griffin, M.D.	Feinstein Institute for Medical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Feinstein Institute for Medical Research		Manhasset	New York	11030	United States

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

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Browse Branches

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