Deep Vein ThrombosisNCT02341937
D-dimer and Pre-test Clinical Probability Score in Cancer Patients With Suspected Deep Vein Thrombosis of the Legs
An observational study of Deep Vein Thrombosis, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
Patients with cancer have a high risk of deep vein thrombosis which often develops in the veins of the lower limbs. The initial evaluation of clinically suspected deep vein thrombosis includes the estimation of the clinical probability by calculating risk scores such as the Wells score and the measurement of the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- Diagnostic tests for suspected deep vein thrombosis
- How many people
- 239 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2014to Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with cancer and clinically suspected DVT of the lower limbs
Who may be able to join
- All patients with cancer and clinically suspected DVT of the lower limbs
Who cannot join
- Ongoing oral or parenteral anticoagulant therapy
- Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
About this study
Patients with cancer have a high risk of deep vein thrombosis which often develops in the veins of the lower limbs. The initial evaluation of clinically suspected deep vein thrombosis includes the estimation of the clinical probability by calculating risk scores such as the Wells score and the measurement of the D-dimer. However, the usefulness and accuracy of the clinical scores and d-dimer test are lower in patients with cancer who often undergo unnecessary (serial) ultrasonography.
The aim of the current study is to analyze variables that predict the presence of thrombosis and may improve the accuracy of the Wells score. In addition, various cut-off of the d-dimer will be evaluated with the goal of improving the sensibility and specificity of the test.
Read the detailed description
Patients with cancer have a high risk of pulmonary embolism and deep vein thrombosis (DVT). The approach to clinically suspected deep vein thrombosis starts with the evaluation of the clinical probability of disease followed by the measurement of the circulating levels of the D-dimer. The presence of the thrombus is objectively demonstrated by compression ultrasonography. In patients without cancer and clinically suspected DVT, a low clinical probability combined with a normal d-dimer result exclude the presence of DVT and compression ultrasonography can be withheld. In patients with cancer, signs and symptoms of the cancer disease may mimic those of DVT shifting the result of the clinical probability scores towards high probabilities. In addition, the presence of cancer is part of the Wells score which further increases the chance to end up with a higher overall score and thus higher probability. Eventually, patients with cancer are more often classified as at high clinical probability than patients without cancer.
The d-dimer test is poorly specific in the presence of cancer disease and its results are often positive as the consequence of the cancer, the cancer treatments or the concomitant comorbidities.
As a result of the poor specificity of the clinical scores and d-dimer test, these initial diagnostic steps have limited usefulness in patients with cancer who often need to undergo ultrasonography.
The aim of the current study is to analyze variables that predict the presence of thrombosis and may improve the accuracy of the Wells score. In addition, various cut-offs of the D-dimer will be evaluated with the goal of improving the sensibility and specificity of the test.
Study design: prospective cohort of cancer patients with clinically suspected DVT.
Objectives: to evaluate the clinical and demographic variables that predict the presence of DVT and may improve the accuracy of the Wells score in cancer patients. The sensibility and specificity of different cut-offs of the D-dimer will be also evaluated.
Inclusion criteria All ambulatory cancer patients with clinically suspected DVT. All patients will be managed with the calculation of the Wells score, the measurement of the D-dimer. The presence of DVT will be ascertained by whole-leg ultrasonography performed independently of the results of the Wells and D-dimer. A phone contact/visit at 3 months will verify the development of venous thromboembolic complications in all patients in whom DVT was initially excluded by ultrasonography.
- Conditions
- Deep Vein Thrombosis
- Being tested
- Diagnostic tests for suspected deep vein thrombosis
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic tests for suspected deep vein thrombosisOther
Pre-test clinical probability (Wells score), D-dimer, compression ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of false negative results of the combination of the modified Wells score and D-dimer results
Measured: 3 months
Secondary outcomes (1)
Sensibility, specificity, positive and negative predictive values of the modified Wells score and D-dimer
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- 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
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcello Di Nisio, G. d'Annunzio University
- Investigators
- Marcello Di Nisio, MD, Principal investigator, University G. D'Annunzio, Chieti, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341937
- Sponsor's protocol ID
- Version n. 1, 10 June 2014
- Status last verified
- Jul 2021
- First submitted
- 14 Jan 2015
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-dimer and Pre-test Clinical Probability Score in Cancer Patients With Suspected Deep Vein Thrombosis of the Legs
- ClinicalTrials.gov ID
- NCT02341937
- Acronym / sponsor ID
- Version n. 1, 10 June 2014
- Conditions
- Deep Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 19 Jan 2015 (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.
Patients with cancer have a high risk of deep vein thrombosis which often develops in the veins of the lower limbs. The initial evaluation of clinically suspected deep vein thrombosis includes the estimation of the clinical probability by calculating risk scores such as the Wells score and the measurement of the D-dimer. However, the usefulness and accuracy of the clinical scores and d-dimer test are lower in patients with cancer who often undergo unnecessary (serial) ultrasonography.
The aim of the current study is to analyze variables that predict the presence of thrombosis and may improve the accuracy of the Wells score. In addition, various cut-off of the d-dimer will be evaluated with the goal of improving the sensibility and specificity of the test.
Detailed description
Patients with cancer have a high risk of pulmonary embolism and deep vein thrombosis (DVT). The approach to clinically suspected deep vein thrombosis starts with the evaluation of the clinical probability of disease followed by the measurement of the circulating levels of the D-dimer. The presence of the thrombus is objectively demonstrated by compression ultrasonography. In patients without cancer and clinically suspected DVT, a low clinical probability combined with a normal d-dimer result exclude the presence of DVT and compression ultrasonography can be withheld. In patients with cancer, signs and symptoms of the cancer disease may mimic those of DVT shifting the result of the clinical probability scores towards high probabilities. In addition, the presence of cancer is part of the Wells score which further increases the chance to end up with a higher overall score and thus higher probability. Eventually, patients with cancer are more often classified as at high clinical probability than patients without cancer.
The d-dimer test is poorly specific in the presence of cancer disease and its results are often positive as the consequence of the cancer, the cancer treatments or the concomitant comorbidities.
As a result of the poor specificity of the clinical scores and d-dimer test, these initial diagnostic steps have limited usefulness in patients with cancer who often need to undergo ultrasonography.
The aim of the current study is to analyze variables that predict the presence of thrombosis and may improve the accuracy of the Wells score. In addition, various cut-offs of the D-dimer will be evaluated with the goal of improving the sensibility and specificity of the test.
Study design: prospective cohort of cancer patients with clinically suspected DVT.
Objectives: to evaluate the clinical and demographic variables that predict the presence of DVT and may improve the accuracy of the Wells score in cancer patients. The sensibility and specificity of different cut-offs of the D-dimer will be also evaluated.
Inclusion criteria All ambulatory cancer patients with clinically suspected DVT. All patients will be managed with the calculation of the Wells score, the measurement of the D-dimer. The presence of DVT will be ascertained by whole-leg ultrasonography performed independently of the results of the Wells and D-dimer. A phone contact/visit at 3 months will verify the development of venous thromboembolic complications in all patients in whom DVT was initially excluded by ultrasonography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with cancer and clinically suspected DVT of the lower limbs
Key inclusion criteria (1 listed)
- All patients with cancer and clinically suspected DVT of the lower limbs
Key exclusion criteria (2 listed)
- Ongoing oral or parenteral anticoagulant therapy
- Unwillingness to participate
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 |
|---|---|---|
| Diagnostic tests for suspected deep vein thrombosisPre-test clinical probability (Wells score), D-dimer, compression ultrasonography | Other | – |
Primary outcome
Proportion of false negative results of the combination of the modified Wells score and D-dimer results
Time frame: 3 months
1 secondary outcome
Sensibility, specificity, positive and negative predictive values of the modified Wells score and D-dimer
Time frame: 3 months
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 15 Jul 2021.
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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.
Marcello Di Nisio, MD principal investigator
University G. D'Annunzio, Chieti, Italy
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 Deep Vein Thrombosis, run by G. d'Annunzio University at 1 site in Italy.
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 2 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 15 Jul 2021. 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 Italy. 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?
Proportion of false negative results of the combination of the modified Wells score and D-dimer results (time frame: 3 months). 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 15 Jul 2021.