Identify Clinical Conditions That Increase Circulating DNA Levels

NCT ID: NCT01815996

Last Updated: 2018-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-07-28

Brief Summary

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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

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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.

Conditions

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Pregnancy Pulmonary Embolism Myocardial Infarction Autoimmune Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant Women

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

Intervention Type OTHER

One time blood draw to look at patient's DNA

Pulmonary Embolism Patients

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

Intervention Type OTHER

One time blood draw to look at patient's DNA

Myocardial Patients

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

Intervention Type OTHER

One time blood draw to look at patient's DNA

Autoimmune Patients

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

Intervention Type OTHER

One time blood draw to look at patient's DNA

Healthy Controls

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

Intervention Type OTHER

One time blood draw to look at patient's DNA

Interventions

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One time blood draw to look at patient's DNA

One time blood draw to look at patient's DNA

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Okunieff, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Shands Davis Cancer Center

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201702171

Identifier Type: OTHER

Identifier Source: secondary_id

407-2012

Identifier Type: -

Identifier Source: org_study_id

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