- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01815996
Identify Clinical Conditions That Increase Circulating DNA Levels (BARDA II)
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
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- Shands Davis Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
- Patients must be willing to undergo a blood draw
- Patients must provide study-specific informed consent prior to study entry
Exclusion Criteria:
1. Patients not meeting the above inclusion criteria
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Paul Okunieff, MD, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 407-2012
- IRB201702171 (Other Identifier: University of Florida)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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