NCT01988805

Brief Summary

This study is intended to collect blood from healthy individuals to investigate whether variations in immune-related (inflammasome) genes affect how the immune cells found in the blood can help fight infections and prevent diseases.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

February 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

October 17, 2014

Status Verified

October 1, 2014

Enrollment Period

1 year

First QC Date

November 14, 2013

Last Update Submit

October 16, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • analyze their ability to respond to exogenous challenges by changing the production of proteins, the expression of genes and their ability to migrate and ingest materials

    Our intent is to collect these cells, divide them into subtypes such as monocytes, lymphocytes and neutrophils and then to analyze their ability to respond to exogenous challenges by changing the production of proteins, the expression of genes and their ability to migrate and ingest materials. We additionally will be interested in examining the cell components that may be released from these cells during various in vitro challenges.

    one visit

Study Arms (1)

Blood Draw

Normal healthy individuals will be consented and their blood drawn at the time of their visit.

Other: Blood Draw

Interventions

Blood Draw

Eligibility Criteria

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

Normal volunteers.

You may qualify if:

  • Healthy with no chronic or acute illnesses, or taking medication which in the opinion of the PI would impact the analyses being conducted.
  • At least 18 years or older.
  • Are capable of reading, understanding and providing written informed consent.

You may not qualify if:

  • Non-English speaking.
  • Individuals under 18 years old.
  • Woman who believe they are or may be pregnant. (Based on self reporting. Pregnancy testing will not be conducted for the purposes of this study)
  • Individuals experiencing acute or chronic illnesses which in the opinion of the PI would impact the analyses being conducted.
  • Currently taking prescription or over the counter medication which in the opinion of the PI would impact the analyses being conducted.
  • Individual has donated blood more than twice in the last week or the amount to be drawn will exceed the maximum allowance in the last 8 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Davis Heart & Lung Research Institute

Columbus, Ohio, United States

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director, Pulmonary Research

Study Record Dates

First Submitted

November 14, 2013

First Posted

November 20, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

October 17, 2014

Record last verified: 2014-10

Locations