Identify Clinical Conditions That Increase Circulating DNA Levels

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01815996

Acronym

BARDA II

Enrollment

130

Registered

2013-03-21

Start date

2012-10-31

Completion date

2016-07-28

Last updated

2018-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Disease, Myocardial Infarction, Pregnancy, Pulmonary Embolism

Keywords

Pregnancy, pulmonary embolism, myocardial infarction, autoimmune disease, healthy controls

Brief summary

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.

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.

Interventions

OTHEROne time blood draw to look at patient's DNA

One time blood draw to look at patient's DNA

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Different diseases will be analysed for the levels of DNA circulating in the blood	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026