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

This study has suspended participant recruitment.
(Due to logistical issues, IRB has suspended the study until pending issues are clarified)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01815996
First received: March 12, 2013
Last updated: October 18, 2013
Last verified: October 2013

March 12, 2013
October 18, 2013
October 2012
September 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01815996 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Identify Clinical Conditions That Increase Circulating DNA Levels
Identify Clinical Conditions That Increase Circulating DNA Levels

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

4-5 ml of blood will be processed and the plasma will be divided into 150 μl aliquots

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.

  • Pregnancy
  • Pulmonary Embolism
  • Myocardial Infarction
  • Autoimmune Disease
Other: One time blood draw to look at patient's DNA
One time blood draw to look at patient's DNA
  • Pregnant Women

    Females between the age of 18-80 who are pregnant

    One time blood draw to look at patient's DNA

    Intervention: Other: 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

    Intervention: Other: 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

    Intervention: Other: 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

    Intervention: Other: 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

    Intervention: Other: One time blood draw to look at patient's DNA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
130
September 2016
September 2015   (final data collection date for primary outcome measure)

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

Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01815996
407-2012
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Paul Okunieff, MD University of Florida
University of Florida
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP