Biomarker Levels During Indwelling Pleural cAtheter Sample Testing (BLAST)
|ClinicalTrials.gov Identifier: NCT02092155|
Recruitment Status : Active, not recruiting
First Posted : March 20, 2014
Last Update Posted : August 18, 2017
|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 2018|
|Estimated Study Completion Date :||December 2018|
|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
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|