Gene Polymorphism Study of Normal Individual Inflammasome Genes

October 16, 2014 updated by: Mark D. Wewers, MD, Ohio State University

Immunological Characterization of Blood and Inflammasome Gene Segment Polymorphism Analysis of Normal Healthy Individuals

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States
        • Davis Heart & Lung Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Normal volunteers.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Non-English speaking.
  2. Individuals under 18 years old.
  3. 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)
  4. Individuals experiencing acute or chronic illnesses which in the opinion of the PI would impact the analyses being conducted.
  5. Currently taking prescription or over the counter medication which in the opinion of the PI would impact the analyses being conducted.
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Blood Draw
Normal healthy individuals will be consented and their blood drawn at the time of their visit.
Other: Blood Draw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: one visit
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

November 14, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Estimate)

October 17, 2014

Last Update Submitted That Met QC Criteria

October 16, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 2012H0346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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