Using Pleural Effusions to Diagnose Cancer (MAPED)
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|ClinicalTrials.gov Identifier: NCT03319472|
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : October 30, 2017
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||1080 participants|
|Official Title:||Clinical Identification of Malignant Pleural Effusions in the Emergency Department|
|Actual Study Start Date :||November 21, 2013|
|Estimated Primary Completion Date :||November 21, 2023|
|Estimated Study Completion Date :||November 21, 2023|
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.
- Diagnosis of Malignancy [ Time Frame: One month post-admission ]Cytologic or histologic evidence of malignant cells or tissues in the pleural space.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319472
|Contact: Georgios T Stathopoulos, MD, PhDfirstname.lastname@example.org|
|Contact: Antonia Marazioti, PhDemail@example.com|
|Patras University Hospital||Recruiting|
|Rio, Achaia, Greece, 26504|
|Contact: Apostolos Voulgaridis, MD 00306972296239 firstname.lastname@example.org|
|Principal Investigator:||Georgios T Stathopoulos, MD, PhD||Associate Professor of Physiology|