Clinical trial · Observational
Biomarker Levels During Indwelling Pleural cAtheter Sample Testing
TGF-B as a Marker of Pleurodesis in Patients With Tunneled Pleural Catheters
NCT02092155CI-TRIAL-00099161BLASTenrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Effusions | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Indwelling tunneled pleural catheter
Primary outcomes (1)
- measure
- To determine the median time to pleurodesis
- timeFrame
- 12 week follow up
- description
- 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 outcomes (1)
- measure
- TGF-B levels over time
- timeFrame
- 12 weeks
- description
- To determine the threshold TGF-B level to determine accuracy of predicting auto-pleurodesis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.