Overview

This trial is active, not recruiting.

Conditions pregnancy, pulmonary embolism, myocardial infarction, autoimmune disease
Treatment one time blood draw to look at patient's dna
Sponsor University of Florida
Start date October 2012
End date July 2017
Trial size 130 participants
Trial identifier NCT01815996, 407-2012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Females between the age of 18-80 who are pregnant One time blood draw to look at patient's DNA
one time blood draw to look at patient's dna
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
one time blood draw to look at patient's dna
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
one time blood draw to look at patient's dna
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
one time blood draw to look at patient's dna
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
one time blood draw to look at patient's dna
One time blood draw to look at patient's DNA

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Identify Clinical Conditions That Increase Circulating DNA Levels
Principal investigator Paul Okunieff, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Florida.