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
  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 ] [ 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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: October 18, 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 August 28, 2014