NCT03027232

Brief Summary

The protocol is to draw peripheral blood from healthy volunteers for in vitro studies. The aims of these in vitro studies are to determine the cellular and intracellular mechanisms by which hypertonic saline and ATP release regulate neutrophil and lymphocyte functions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

11 years

First QC Date

January 13, 2017

Last Update Submit

April 26, 2018

Conditions

Keywords

infection

Outcome Measures

Primary Outcomes (1)

  • Immune cells will be studied in vitro to learn about basic mechanisms of immune cell signaling.

    The purpose of this study is to obtain blood from healthy subjects (volunteers) for in vitro studies to explore how immune cells function. Cells will be isolated and subjected to various tests including stimuli that simulate immune cell activation in health and disease. Subjects will not be subjected to any treatments. Only some of the cells (leukocytes) in the blood will be studied. For example, activation events such as cytokine production, the ability of leukocytes (=immune cells) to detect and respond to bacterial products will be assessed. No identifiable information about study subjects will be kept.

    Blood is collected as needed; time frame: indefinitely. Blood used between 1-7 days after blood draws.

Interventions

No drugs or interventions are given. Single purpose is to draw blood from healthy subjects to study immune cell biology in vitro. No records about subjects to be kept.

Eligibility Criteria

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

Normal healthy volunteers

You may qualify if:

  • any healthy volunteer

You may not qualify if:

  • pregnancy
  • needing/using drugs
  • inflammatory or infectious complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BIDMC

Boston, Massachusetts, 02215, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood is collected from all subjects in the same fashion. Purpose: isolation of immune cells for in vitro studies of cell function. This is an observational study in human beings in predefined groups of individuals who are healthy and volunteer to donate blood for laboratory science studies. Subjects in the study receive neither diagnostic, therapeutic, nor other interventions, and the investigator does not assign specific interventions to any of the subjects of the study.

MeSH Terms

Conditions

EncephalitisInfections

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 23, 2017

Study Start

January 1, 2007

Primary Completion

December 15, 2017

Study Completion

December 15, 2017

Last Updated

April 27, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations