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.

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Key information

Conditions

Pregnancy Autoimmune Disease Autoimmune Diseases Cardiovascular Diseases Embolism Embolism and Thrombosis Heart Diseases Immune System Diseases Infarction Ischemia Lung Diseases Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shands Davis Cancer Center

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Patients not meeting the above inclusion criteria

Treatment and study plan

One time blood draw to look at patient's DNA

Other

One time blood draw to look at patient's DNA

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: BARDA II

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Mar 21, 2013
Registry last updated: Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed