Identify Clinical Conditions That Increase Circulating DNA Levels

Pregnancy Clinical Trial

— BARDA II  

Official title:

Identify Clinical Conditions That Increase Circulating DNA Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815996
• Other study ID #: 407-2012
• Secondary ID: IRB201702171
• Status: Completed
• Start date: October 2012
• Est. completion date: July 28, 2016

Study information

• Verified date: November 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 28, 2016
• Est. primary completion date: July 28, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Disease
• Autoimmune Diseases
• Embolism
• Infarction
• Myocardial Infarction
• Pregnancy
• Pulmonary Embolism

Intervention

Other:
• One time blood draw to look at patient's DNA
One time blood draw to look at patient's DNA

Locations

Country	Name	City	State
United States	Shands Davis Cancer Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Different diseases will be analysed for the levels of DNA circulating in the blood	To determine what medical conditions and disease states might increase circulating DNA levels at a magnitude similar to whole body irradiation.	blood will be tested up to 1 year after collection