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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01815996
First Posted: March 21, 2013
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA
4-5 ml of blood will be processed and the plasma will be divided into 150 μl aliquots

Enrollment: 130
Actual Study Start Date: October 2012
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2018 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815996


Locations
United States, Florida
Shands Davis Cancer Center
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Paul Okunieff, MD University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01815996     History of Changes
Other Study ID Numbers: 407-2012
First Submitted: March 12, 2013
First Posted: March 21, 2013
Last Update Posted: August 1, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Pregnancy
pulmonary embolism
myocardial infarction
autoimmune disease
healthy controls

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Embolism
Pulmonary Embolism
Autoimmune Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Immune System Diseases