Pleural EffusionMAPEDNCT03319472
Using Pleural Effusions to Diagnose Cancer
An observational study of Pleural Effusion, run by University of Patras at 1 site in Greece.
Trial summary
Pleural effusions (PE) are common conditions that signal either infection or cancer. The investigators aim to develop, validate, and prospectively assess the MAPED score, a clinical score that predicts malignancy at admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- How many people
- 439 participants
- Where
- 1 siteGreece
- Study dates
- 21 Nov 2013to 21 Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to a tertiary hospital with a pleural effusion.
Who may be able to join
- Pleural effusion
- Hospital admission
- No previous pleural procedure
- Age > 18 years
- No previous chemoradiotherapy
- No antibiotic therapy during previous trimester
- All history, chest X-ray, and pleural and blood cell counts and biochemistry entry data obtained within 4 hours after admission
Who cannot join
- No diagnosis at one month post-admission
- No informed consent provided
- Age < 18 years
- History, chest X-ray, or pleural and blood cell counts and biochemistry entry data obtained later than 4 hours after admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Identification of Malignant Pleural Effusions in the Emergency Department
Pleural effusions (PE) are common conditions that signal either infection or cancer. The investigators aim to develop, validate, and prospectively assess the MAPED score, a clinical score that predicts malignancy at admission. This tool will assist clinicians all over the world to rapidly assess the probability of an effusion being malignant within 4 hours of admission.
Read the detailed description
Background: Pleural effusions (PE) are common conditions that signal either pleural-disseminated infection or cancer. While these diagnoses bear tremendous importance for patients, they require invasive procurement of pleural tissues and/or cells and time. Simple and rapid diagnostic markers of pleural malignancy at admission that streamline diagnostic and treatment efforts remain unidentified.
Objective: To develop, validate, and prospectively assess markers of malignancy of PE at admission.
Methods: A prospective cohort of patients with PE from different etiologies will be recruited stating on 11.21.2013 and prospectively ending on 11.21.2023. Data will be collected within 4 hours of admission including history, chest X-ray, and blood and pleural fluid (PF) cell counts and basic biochemistry. Pleural fluid and serum will be biobanked for future analyses. Patients will sign informed consent forms. Diagnosis will be confirmed using standard microbiology, cytology, histology, and imaging techniques. Patients undiagnosed within a month will be excluded. Variables will be entered into binary regression and receiver-operator analyses using malignancy as the target to develop the MAPED score, a clinical score that predicts malignancy at admission. MAPED will be retrospectively validated in separate published cohorts from the first therapeutic interventions in malignant effusion (TIME) 1-3 trials from Oxford UK. Data will be censored and analyzed three times, at 40-month intervals since study initiation.
- Conditions
- Pleural Effusion
- Keywords
- malignant, cancer, simple bedside test, rapid, score, widely available, feasible
- Medical subject headings
- Pleural Effusion, Neoplasms, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Benign Pleural Effusion | Patients that will be diagnosed within a month from admission with any non-malignant cause of pleural effusion, including but not limited to effusions caused by common or tuberculous or fungal infection, heart failure, etc. Documentation of the etiology will be required for inclusion in this group, including but not limited to bacteriology, virology, PCR, radiology, heart echocardiogram or catheterization, as appropriate. | |
| Malignant Pleural Effusion | Patients that will be diagnosed within a month from admission with any malignant cause of pleural effusion, including but not limited to effusions caused by lung, breast, colon, ovary, mesothelial, hematopoietic, prostate, or any other cancer. Diagnosis will be based on verification of the presence of malignant cells in the pleural fluid or tissues. Patients with cancer and an effusion without such documentation will be assigned to the benign group if an alternative diagnosis is made. In any other case, they will be excluded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Malignancy
Cytologic or histologic evidence of malignant cells or tissues in the pleural space.
Measured: One month post-admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start21 Nov 2013
- Primary completion21 Nov 2017
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies 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
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Stathopoulos, University of Patras
- Investigators
- Georgios T Stathopoulos, MD, PhD, Principal investigator, Associate Professor of Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319472
- Sponsor's protocol ID
- 22699/21.11.2013
- Acronym
- MAPED
- Status last verified
- Dec 2019
- First submitted
- 19 Oct 2017
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Identification of Malignant Pleural Effusions in the Emergency Department
- ClinicalTrials.gov ID
- NCT03319472
- Acronym / sponsor ID
- MAPED / 22699/21.11.2013
- Conditions
- Pleural Effusion
- Keywords
- malignant, cancer, simple bedside test, rapid, score, widely available, feasible
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- 21 Nov 2013 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 24 Oct 2017 (actual)
- 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.
Pleural effusions (PE) are common conditions that signal either infection or cancer. The investigators aim to develop, validate, and prospectively assess the MAPED score, a clinical score that predicts malignancy at admission. This tool will assist clinicians all over the world to rapidly assess the probability of an effusion being malignant within 4 hours of admission.
Detailed description
Background: Pleural effusions (PE) are common conditions that signal either pleural-disseminated infection or cancer. While these diagnoses bear tremendous importance for patients, they require invasive procurement of pleural tissues and/or cells and time. Simple and rapid diagnostic markers of pleural malignancy at admission that streamline diagnostic and treatment efforts remain unidentified.
Objective: To develop, validate, and prospectively assess markers of malignancy of PE at admission.
Methods: A prospective cohort of patients with PE from different etiologies will be recruited stating on 11.21.2013 and prospectively ending on 11.21.2023. Data will be collected within 4 hours of admission including history, chest X-ray, and blood and pleural fluid (PF) cell counts and basic biochemistry. Pleural fluid and serum will be biobanked for future analyses. Patients will sign informed consent forms. Diagnosis will be confirmed using standard microbiology, cytology, histology, and imaging techniques. Patients undiagnosed within a month will be excluded. Variables will be entered into binary regression and receiver-operator analyses using malignancy as the target to develop the MAPED score, a clinical score that predicts malignancy at admission. MAPED will be retrospectively validated in separate published cohorts from the first therapeutic interventions in malignant effusion (TIME) 1-3 trials from Oxford UK. Data will be censored and analyzed three times, at 40-month intervals since study initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benign Pleural Effusion | – | –Patients that will be diagnosed within a month from admission with any non-malignant cause of pleural effusion, including but not limited to effusions caused by common or tuberculous or fungal infection, heart failure, etc. Documentation of the etiology will be required for inclusion in this group, including but not limited to bacteriology, virology, PCR, radiology, heart echocardiogram or catheterization, as appropriate. |
| Malignant Pleural Effusion | – | –Patients that will be diagnosed within a month from admission with any malignant cause of pleural effusion, including but not limited to effusions caused by lung, breast, colon, ovary, mesothelial, hematopoietic, prostate, or any other cancer. Diagnosis will be based on verification of the presence of malignant cells in the pleural fluid or tissues. Patients with cancer and an effusion without such documentation will be assigned to the benign group if an alternative diagnosis is made. In any other case, they will be excluded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to a tertiary hospital with a pleural effusion.
Key inclusion criteria (7 listed)
- Pleural effusion
- Hospital admission
- No previous pleural procedure
- Age > 18 years
- No previous chemoradiotherapy
Key exclusion criteria (4 listed)
- No diagnosis at one month post-admission
- No informed consent provided
- Age < 18 years
- History, chest X-ray, or pleural and blood cell counts and biochemistry entry data obtained later than 4 hours after admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of Malignancy
Time frame: One month post-admission
Cytologic or histologic evidence of malignant cells or tissues in the pleural space.
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 10 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
Georgios T Stathopoulos, MD, PhD principal investigator
Associate Professor of Physiology
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 Pleural Effusion, run by University of Patras at 1 site in Greece.
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 7 inclusion and 4 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 10 Dec 2019. 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 Greece. 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?
Diagnosis of Malignancy (time frame: One month post-admission). 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 10 Dec 2019.