Identify Clinical Conditions That Increase Circulating DNA Levels (BARDA II)

November 20, 2018 updated by: University of Florida

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

130

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

    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands Davis Cancer Center

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Seeking healthy volunteers, pregnant women, patients who recently suffered a heart attach or pulmonary embolism, and patiebts with autoimmune disease. Patients who are health individuals will also be asked to participate.

Description

Inclusion Criteria:

  1. Patients must be adults in one of the following categories:

    • Pregnant
    • Suffered a pulmonary embolism within the past 48 hours
    • Myocardial infarction in the past 48 hours
    • Diagnosed with an autoimmune disease
    • Adults age 18-80
    • Self-declared healthy adults
  2. Patients must be willing to undergo a blood draw
  3. Patients must provide study-specific informed consent prior to study entry

Exclusion Criteria:

1. Patients not meeting the above inclusion criteria

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant Women

Females between the age of 18-80 who are pregnant

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

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

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

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

One time blood draw to look at patient's DNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Different diseases will be analysed for the levels of DNA circulating in the blood
Time Frame: 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.
blood will be tested up to 1 year after collection

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Paul Okunieff, MD, University of Florida

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 (Actual)

October 1, 2012

Primary Completion (Actual)

July 28, 2016

Study Completion (Actual)

July 28, 2016

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 20, 2013

First Posted (Estimate)

March 21, 2013

Study Record Updates

Last Update Posted (Actual)

November 21, 2018

Last Update Submitted That Met QC Criteria

November 20, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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