CancerNCT00615147
Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population
An observational study of Cancer and Pulmonary Embolism, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see if a blood test (D-dimer) is as precise as the CT scan for the detection of clots. A pulmonary embolism is an obstruction of the blood vessels in your lungs usually due to a blood clot that travels to the lungs usually from the leg. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer, Pulmonary Embolism
- What is being tested?
- CT pulmonary angiogram and d-dimer draw
- Type of treatment
- Surgery or procedure
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jun 2008
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients coming to MSKCC Urgent care unit
Who may be able to join
- All patients evaluated in the urgent care center and determined to need with CT pulmonary angiogram to rule out pulmonary embolism based on signs and symptoms such as dyspnea, pleuritic chest pain, tachycardia, and/or pulse oxygen desaturation will be included.
Who cannot join
- Inability to obtain CT pulmonary angiogram secondary to lack of IV access, contrast allergy or lack of consent.
- CT pulmonary angiogram not done with routine protocol for rule out pulmonary embolism.
- Less than 21 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population: A Correlation With Ct Pulmonary Angiogram in the Urgent Care Setting
The purpose of this study is to see if a blood test (D-dimer) is as precise as the CT scan for the detection of clots.
A pulmonary embolism is an obstruction of the blood vessels in your lungs usually due to a blood clot that travels to the lungs usually from the leg. Research has shown that the results of a specific blood test (D-dimer) can be used instead of a CT scan to diagnose clots. D-dimer is a valuable diagnostic marker in either detecting the presence of or monitoring the progress of blood clots. D-dimer assays have proven to be a beneficial diagnostic tool in the evaluation of patients with suspected pulmonary embolism (PE).
- Conditions
- Cancer, Pulmonary Embolism
- Being tested
- CT pulmonary angiogram and d-dimer draw
- Keywords
- Any cancer, suspected pulmonary embolism
- Medical subject headings
- Neoplasms, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT pulmonary angiogram and d-dimer drawProcedure or surgery
A CT pulmonary angiogram and a d-dimer drawn within 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients to have a CT pulmonary angiogram for suspected pulmonary embolism will have a d-dimer drawn as is routinely done. Receives: Procedure: CT pulmonary angiogram and d-dimer draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
The negative predictive value of the d-dimer assay relative to CT pulmonary angiogram will be the primary measure of accuracy used for this purpose.
Measured: conclusion of study
Secondary outcomes (2)
To estimate the positive predictive value, sensitivity, and specificity of the d-dimer assay relative to CT pulmonary angiogram.
Measured: conclusion of study
To explore the association between the accuracy of the d-dimer assay and clinical symptoms indicating pulmonary embolism.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startMay 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615147
- Sponsor's protocol ID
- 05-040
- Status last verified
- Jan 2012
- First submitted
- 1 Feb 2008
- Last updated
- 9 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population: A Correlation With Ct Pulmonary Angiogram in the Urgent Care Setting
- ClinicalTrials.gov ID
- NCT00615147
- Acronym / sponsor ID
- 05-040
- Conditions
- Cancer, Pulmonary Embolism
- Keywords
- Any cancer, suspected pulmonary embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 14 Feb 2008 (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 purpose of this study is to see if a blood test (D-dimer) is as precise as the CT scan for the detection of clots.
A pulmonary embolism is an obstruction of the blood vessels in your lungs usually due to a blood clot that travels to the lungs usually from the leg. Research has shown that the results of a specific blood test (D-dimer) can be used instead of a CT scan to diagnose clots. D-dimer is a valuable diagnostic marker in either detecting the presence of or monitoring the progress of blood clots. D-dimer assays have proven to be a beneficial diagnostic tool in the evaluation of patients with suspected pulmonary embolism (PE).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: CT pulmonary angiogram and d-dimer drawPatients to have a CT pulmonary angiogram for suspected pulmonary embolism will have a d-dimer drawn as is routinely done. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients coming to MSKCC Urgent care unit
Key inclusion criteria (1 listed)
- All patients evaluated in the urgent care center and determined to need with CT pulmonary angiogram to rule out pulmonary embolism based on signs and symptoms such as dyspnea, pleuritic chest pain, tachycardia, and/or pulse oxygen desaturation will be included.
Key exclusion criteria (3 listed)
- Inability to obtain CT pulmonary angiogram secondary to lack of IV access, contrast allergy or lack of consent.
- CT pulmonary angiogram not done with routine protocol for rule out pulmonary embolism.
- Less than 21 years of age
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 |
|---|---|---|
| CT pulmonary angiogram and d-dimer drawA CT pulmonary angiogram and a d-dimer drawn within 24 hours. | Procedure or surgery | 1 |
Primary outcome
The negative predictive value of the d-dimer assay relative to CT pulmonary angiogram will be the primary measure of accuracy used for this purpose.
Time frame: conclusion of study
2 secondary outcomes
To estimate the positive predictive value, sensitivity, and specificity of the d-dimer assay relative to CT pulmonary angiogram.
Time frame: conclusion of study
To explore the association between the accuracy of the d-dimer assay and clinical symptoms indicating pulmonary embolism.
Time frame: conclusion of study
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 9 Jan 2012.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer and Pulmonary Embolism, run by Memorial Sloan Kettering Cancer Center 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 1 inclusion and 3 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 9 Jan 2012. 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?
The negative predictive value of the d-dimer assay relative to CT pulmonary angiogram will be the primary measure of accuracy used for this purpose. (time frame: conclusion of study). 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 9 Jan 2012.