Biomarker Levels During Indwelling Pleural cAtheter Sample Testing (BLAST)
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|ClinicalTrials.gov Identifier: NCT02092155|
Recruitment Status : Enrolling by invitation
First Posted : March 20, 2014
Last Update Posted : January 6, 2020
|Condition or disease|
|Malignant Pleural Effusions|
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|
|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 2020|
|Estimated Study Completion Date :||December 2020|
|Indwelling tunneled pleural catheter|
- 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.
- 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
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
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Lonny Yarmus, DO||Johns Hopkins University|