Malignant Pleural EffusionsBLASTNCT02092155
Biomarker Levels During Indwelling Pleural cAtheter Sample Testing
An observational study of Malignant Pleural Effusions, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Malignant Pleural Effusions
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the interventional pulmonology team who receive indwelling pleural catheters for a malignant pleural effusion.
Who may be able to join
- Pleural effusion (etiology fulfilling one of the following criteria):
- Malignant effusion confirmed by cytology or pleural biopsy
- exudative effusion in the setting of known malignancy with no other identifiable cause
- 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
Show all 9Show fewer
- Demonstration of symptomatic improvement after therapeutic thoracentesis
- Recurrent pleural effusion after therapeutic thoracentesis
- Capacity to provide informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: TGF-B as a Marker of Pleurodesis in Patients With Tunneled Pleural Catheters
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.
Read the 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.
- Conditions
- Malignant Pleural Effusions
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Indwelling tunneled pleural catheter | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the median time to pleurodesis
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.
Measured: 12 week follow up
Secondary outcomes (1)
TGF-B levels over time
To determine the threshold TGF-B level to determine accuracy of predicting auto-pleurodesis
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lonny Yarmus, DO, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092155
- Sponsor's protocol ID
- IRB00044267
- Acronym
- BLAST
- Status last verified
- Dec 2025
- First submitted
- 17 Mar 2014
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TGF-B as a Marker of Pleurodesis in Patients With Tunneled Pleural Catheters
- ClinicalTrials.gov ID
- NCT02092155
- Acronym / sponsor ID
- BLAST / IRB00044267
- Conditions
- Malignant Pleural Effusions
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indwelling tunneled pleural catheter | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the interventional pulmonology team who receive indwelling pleural catheters for a malignant pleural effusion.
Key inclusion criteria (9 listed)
- Pleural effusion (etiology fulfilling one of the following criteria):
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
TGF-B levels over time
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lonny Yarmus, DO principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Pleural Effusions, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the median time to pleurodesis (time frame: 12 week follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.