Identify Clinical Conditions That Increase Circulating DNA Levels

Completed

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

• Registration Number: NCT01815996
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-21
• Primary Completion: 2016-07-28
• Study Completion: 2016-07-28
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-20
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

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Exclusion Criteria

1. Patients not meeting the above inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	One time blood draw to look at patient's DNA	Self-declared healthy adults (men and women). One time blood draw to look at patient's DNA
Pregnant Women	One time blood draw to look at patient's DNA	Females between the age of 18-80 who are pregnant One time blood draw to look at patient's DNA
Pulmonary Embolism Patients	One time blood draw to look at patient's DNA	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
Myocardial Patients	One time blood draw to look at patient's DNA	Male and Female patients who have myocardial infarction in the past 48 hours. One time blood draw to look at patient's DNA
Autoimmune Patients	One time blood draw to look at patient's DNA	Male and Female patients that have been diagnosed with an Autoimmune disease One time blood draw to look at patient's DNA

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Shands Davis Cancer Center; 🇺🇸 Gainesville, Florida, United States