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Trial record 1 of 10 for:    MALIGNANT PLEURAL EFFUSION MARYLAND
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Biomarker Levels During Indwelling Pleural cAtheter Sample Testing (BLAST)

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ClinicalTrials.gov Identifier: NCT02092155
Recruitment Status : Active, not recruiting
First Posted : March 20, 2014
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Some patients that have a tunneled pleural catheter will not have the pleural fluid (water around the lung) return after some time (pleurodesis). The purpose of this study is to understand how the investigators can predict who will achieve pleurodesis and how this occurs by studying the pleural effusion.

Condition or disease
Malignant Pleural Effusions

Detailed Description:

An alternative and emerging treatment for malignant pleural effusions is the placement of a chronic indwelling pleural catheter.

Tunneled pleural catheters (TPC) are ideal for treatment of malignant pleural effusion (MPE) associated with a trapped or non-expandable lung which will not have sufficient visceral and parietal pleura apposition for chemical pleurodesis. Transforming growth factor-Beta 1 (TGF-β) is a profibrotic cytokine, and a potent inducer of Plasminogen activator inhibitor-1 (PAI-1) in human pleural mesothelial cells. PAI-1 inhibits protease-dependent fibrinolytic activity and along with TGF-β, its concentration is increased in exudative and tuberculous pleural effusion. TGF-β levels in pleural fluid have been shown to correlate with pleural thickness in tuberculosis pleurisy and empyema in rabbits.

TGF-β is a multifunctional cytokine primarily produced by mesothelial cells in the pleural space, but can also originate from lung parenchymal macrophages that migrate to the pleural space. In humans, TGF-β consists of three isoforms (TGF-β1, TGF-β2, and TGF-β3). They share many biological activities and their actions on cells are qualitatively similar in most cases. TGF-β stimulates the extracellular matrix production and studies support that TGF-β over-production is a key regulator in pleural fibrosis and chemical pleurodesis. Moreover, TGF-β signaling for the production of PAI-1 is clearly noted in human mesothelial cells of different origins. Different inflammatory stimuli in the pleural space including malignancy and infection may activate TGF-β up-regulation and enhanced production which in turns results in PAI-1 expression.


Study Type : Observational
Estimated Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TGF-B as a Marker of Pleurodesis in Patients With Tunneled Pleural Catheters
Study Start Date : January 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort
Indwelling tunneled pleural catheter



Primary Outcome Measures :
  1. To determine the median time to pleurodesis [ Time Frame: 12 week follow up ]
    Duration of follow-up will be 12 weeks. After 12 weeks, all patients who do not achieve spontaneous pleurodesis will adhere to the standard drainage protocol.


Secondary Outcome Measures :
  1. TGF-B levels over time [ Time Frame: 12 weeks ]
    To determine the threshold TGF-B level to determine accuracy of predicting auto-pleurodesis


Biospecimen Retention:   Samples Without DNA
Pleural fluid attained during drainage of indwelling pleural catheter


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of the interventional pulmonology team who receive indwelling pleural catheters for a malignant pleural effusion.
Criteria

Inclusion criteria:

  • Pleural effusion (etiology fulfilling one of the following criteria):

    1. Malignant effusion confirmed by cytology or pleural biopsy
    2. exudative effusion in the setting of known malignancy with no other identifiable cause
    3. Malignant effusion due to tumors that are historically rapidly responsive to systemic therapy (small cell lung cancer, hematological malignancies) will only be included if refractory to standard chemotherapy
  • 18 years of age
  • Symptoms such as shortness of breath, cough, or chest fullness/chest discomfort
  • Demonstration of symptomatic improvement after therapeutic thoracentesis
  • Recurrent pleural effusion after therapeutic thoracentesis
  • Capacity to provide informed consent

Exclusion criteria:

  • Projected life expectancy less than 30 days.
  • Radiographic evidence of trapped lung - persistent lung collapse with failure of the majority (>50%) of the lung to reexpand following drainage of a pleural effusion
  • Previous lobectomy or pneumonectomy on the affected side
  • Patient receiving intrapleural chemotherapy
  • Chylothorax - pleural effusion with triglyceride levels > 110 mg/dl or chylomicrons on lipoprotein analysis, most commonly due to trauma/obstruction of the thoracic duct
  • Parapneumonic effusion - pleural effusion associated with pneumonia
  • Empyema - infected pleural space as defined by purulent pleural fluid, positive gram stain, or positive culture
  • Inability to adequately perform pleural drainage at home
  • Uncorrectable bleeding disorder
  • Skin infection at the site of intended catheter insertion
  • Pregnant women - detected by spot urine testing prior to the procedure

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): NCT02092155


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Lonny Yarmus, DO Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02092155     History of Changes
Other Study ID Numbers: NA_00086126
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms