Pregnancy Clinical Trial
— BARDA IIOfficial title:
Identify Clinical Conditions That Increase Circulating DNA Levels
Verified date | November 2018 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Shands Davis Cancer Center | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
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 |
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