Identify Clinical Conditions That Increase Circulating DNA Levels (BARDA II)
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Purpose
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 | Intervention |
|---|---|
|
Pregnancy Pulmonary Embolism Myocardial Infarction Autoimmune Disease |
Other: One time blood draw to look at patient's DNA |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Identify Clinical Conditions That Increase Circulating DNA Levels |
- 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 ] [ Designated as safety issue: No ]To determine what medical conditions and disease states might increase circulating DNA levels at a magnitude similar to whole body irradiation.
Biospecimen Retention: Samples With DNA
4-5 ml of blood will be processed and the plasma will be divided into 150 μl aliquots
| Estimated Enrollment: | 130 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| Contact: Rebecca Beaulieu, MS | 352-265-0680 ext 87818 | schmir@shands.ufl.edu |
| United States, Florida | |
| Shands Davis Cancer Center | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Rebecca Beaulieu, MS 352-265-0680 ext 87818 schmir@shands.ufl.edu | |
| Principal Investigator: Paul Okunieff, MD | |
| Principal Investigator: | Paul Okunieff, MD | University of Florida |
More Information
No publications provided
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01815996 History of Changes |
| Other Study ID Numbers: | 407-2012 |
| Study First Received: | March 12, 2013 |
| Last Updated: | March 20, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Florida:
|
Pregnancy pulmonary embolism myocardial infarction autoimmune disease healthy controls |
Additional relevant MeSH terms:
|
Autoimmune Diseases Embolism Infarction Myocardial Infarction Pulmonary Embolism Immune System Diseases Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013