PregnancyBARDA IINCT01815996
Identify Clinical Conditions That Increase Circulating DNA Levels
An observational study of Pregnancy and Pulmonary Embolism, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Pulmonary Embolism, Myocardial Infarction
- What is being tested?
- One time blood draw to look at patient's DNA
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 28 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Seeking healthy volunteers, pregnant women, patients who recently suffered a heart attach or pulmonary embolism, and patiebts with autoimmune disease. Patients who are health individuals will also be asked to participate.
Who may be able to join
- 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
Show all 9Show fewer
- Self-declared healthy adults
- Patients must be willing to undergo a blood draw
- Patients must provide study-specific informed consent prior to study entry
Who cannot join
- 1. Patients not meeting the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands Davis Cancer Center
Gainesville, Florida, 32610
About this study
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.
Read the 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.
- Being tested
- One time blood draw to look at patient's DNA
- Keywords
- Pregnancy, pulmonary embolism, myocardial infarction, autoimmune disease, healthy controls
- Medical subject headings
- Pulmonary Embolism, Myocardial Infarction, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One time blood draw to look at patient's DNAOther
One time blood draw to look at patient's DNA
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Females between the age of 18-80 who are pregnant
One time blood draw to look at patient's DNA Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: One time blood draw to look at patient's DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: blood will be tested up to 1 year after collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startOct 2012
- Primary completion28 Jul 2016
- Study completion28 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Okunieff, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815996
- Sponsor's protocol ID
- 407-2012
- Other IDs
- IRB201702171
- Acronym
- BARDA II
- Status last verified
- Nov 2018
- First submitted
- 12 Mar 2013
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identify Clinical Conditions That Increase Circulating DNA Levels
- ClinicalTrials.gov ID
- NCT01815996
- Acronym / sponsor ID
- BARDA II / 407-2012
- Keywords
- Pregnancy, pulmonary embolism, myocardial infarction, autoimmune disease, healthy controls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- 28 Jul 2016 (actual)
- Study completion
- 28 Jul 2016 (actual)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Other: One time blood draw to look at patient's DNAFemales between the age of 18-80 who are pregnant One time blood draw to look at patient's DNA |
| Pulmonary Embolism Patients | – | Other: One time blood draw to look at patient's DNAMale 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 | – | Other: One time blood draw to look at patient's DNAMale and Female patients who have myocardial infarction in the past 48 hours. One time blood draw to look at patient's DNA |
| Autoimmune Patients | – | Other: One time blood draw to look at patient's DNAMale and Female patients that have been diagnosed with an Autoimmune disease One time blood draw to look at patient's DNA |
| Healthy Controls | – | Other: One time blood draw to look at patient's DNASelf-declared healthy adults (men and women). One time blood draw to look at patient's DNA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Seeking healthy volunteers, pregnant women, patients who recently suffered a heart attach or pulmonary embolism, and patiebts with autoimmune disease. Patients who are health individuals will also be asked to participate.
Key inclusion criteria (9 listed)
- Patients must be adults in one of the following categories:
- Patients must be willing to undergo a blood draw
- Patients must provide study-specific informed consent prior to study entry
Key exclusion criteria (1 listed)
- 1. Patients not meeting the above inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One time blood draw to look at patient's DNAOne time blood draw to look at patient's DNA | Other | Autoimmune Patients, Healthy Controls, Myocardial Patients, Pregnant Women, Pulmonary Embolism Patients |
Primary outcome
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
To determine what medical conditions and disease states might increase circulating DNA levels at a magnitude similar to whole body irradiation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Okunieff, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Pulmonary Embolism, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.