Gene Polymorphism Study of Normal Individual Inflammasome Genes

Healthy Individuals Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01988805
• Other study ID #: 2012H0346
• Status: Withdrawn
• Phase: N/A
• First received: November 14, 2013
• Last updated: October 16, 2014
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: October 2014
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Healthy Individuals

Intervention

Other:
• Blood Draw

Locations

Country	Name	City	State
United States	Davis Heart & Lung Research Institute	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No