BARDA II: Identify Clinical Conditions That Increase Circulating DNA Levels

Sponsor

University of Florida (Other)

Overall Status

Completed

CT.gov ID

NCT01815996

Collaborator

(none)

130

Enrollment

Location

45.9

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators are developing a test that is expected to measure the amount of radiation a patient has been exposed to after a nuclear bomb. The investigator will do this by measuring the DNA in the patients blood from cells killed by the radiation.

Many diseases and medical conditions can put DNA in the blood. The investigator needs to know how much DNA in order to better interpret our radiation detection test. Therefore, the investigator is collecting blood from several patients with different diseases or medical conditions and also healthy volunteers to measure their DNA content.

Patients that will be included in this study are pregnant women, patients who have suffered a pulmonary embolism within the past 48 hours, patients who have suffered from myocardial infarction in the past 48 hours, patients with autoimmune diseases and health patients.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Pulmonary Embolism Myocardial Infarction Autoimmune Disease	Other: One time blood draw to look at patient's DNA

Detailed Description

The investigator will collect 8 mL (one and one half teaspoons) of blood one time only. The investigator may also collect the patient's past medical history, test results and disease treatment.

Study Design

Study Type:

Observational

Actual Enrollment :

130 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Identify Clinical Conditions That Increase Circulating DNA Levels

Actual Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Jul 28, 2016

Actual Study Completion Date :

Jul 28, 2016

Arms and Interventions

Arm	Intervention/Treatment
Pregnant Women Females between the age of 18-80 who are pregnant One time blood draw to look at patient's DNA	Other: One time blood draw to look at patient's DNA One time blood draw to look at patient's DNA
Pulmonary Embolism Patients Male and Female patients that have suffered a pulmonary embolism within the past 48 hours One time blood draw to look at patient's DNA	Other: One time blood draw to look at patient's DNA One time blood draw to look at patient's DNA
Myocardial Patients Male and Female patients who have myocardial infarction in the past 48 hours. One time blood draw to look at patient's DNA	Other: One time blood draw to look at patient's DNA One time blood draw to look at patient's DNA
Autoimmune Patients Male and Female patients that have been diagnosed with an Autoimmune disease One time blood draw to look at patient's DNA	Other: One time blood draw to look at patient's DNA One time blood draw to look at patient's DNA
Healthy Controls Self-declared healthy adults (men and women). One time blood draw to look at patient's DNA	Other: One time blood draw to look at patient's DNA One time blood draw to look at patient's DNA

Outcome Measures

Primary Outcome Measures

Different diseases will be analysed for the levels of DNA circulating in the blood [blood will be tested up to 1 year after collection]
To determine what medical conditions and disease states might increase circulating DNA levels at a magnitude similar to whole body irradiation.