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Trial record 3 of 65 for:    Recruiting, Not yet recruiting, Available Studies | "Pleural Effusion"

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
Sponsor:
Information provided by (Responsible Party):
Georgios Stathopoulos, University of Patras

Brief 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. This tool will assist clinicians all over the world to rapidly assess the probability of an effusion being malignant within 4 hours of admission.

Condition or disease
Pleural Effusion

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.


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Study Type : Observational
Estimated Enrollment : 1080 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
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.



Primary Outcome Measures :
  1. 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
Pleural fluid will be centrifuged and cells will be separated from supernatants. The latter will be stored together with matched serum samples at -80 degrees C. Cell pellets will be stored in DMEM 10% FBS, 2 % DMSO at the same temperature.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted to a tertiary hospital with a pleural effusion.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Georgios T Stathopoulos, MD, PhD 00302610969154 gstathop@upatras.gr
Contact: Antonia Marazioti, PhD 00302610969116 amarazioti@upatras.gr

Locations
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Greece
Patras University Hospital Recruiting
Rio, Achaia, Greece, 26504
Contact: Apostolos Voulgaridis, MD    00306972296239    apovoulga@gmail.com   
Sponsors and Collaborators
University of Patras
Investigators
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Principal Investigator: Georgios T Stathopoulos, MD, PhD Associate Professor of Physiology

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Responsible Party: Georgios Stathopoulos, Associate Professor of Physiology, University of Patras
ClinicalTrials.gov Identifier: NCT03319472     History of Changes
Other Study ID Numbers: 22699/21.11.2013
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Georgios Stathopoulos, University of Patras:
malignant
cancer
simple bedside test
rapid
score
widely available
feasible

Additional relevant MeSH terms:
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Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases