Biomarker Levels During Indwelling Pleural cAtheter Sample Testing

NCT02092155 | Enrolling By Invitation

• 1 other identifier: IRB00044267
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Pleural Effusions

Outcome Measures

Primary Outcomes (1)

• 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.

  12 week follow up

Secondary Outcomes (1)

• TGF-B levels over time

  12 weeks

Study Arms (1)

Indwelling tunneled pleural catheter

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the interventional pulmonology team who receive indwelling pleural catheters for a malignant pleural effusion.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pleural fluid attained during drainage of indwelling pleural catheter

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Lonny Yarmus, DO

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 20, 2014
• Study Start: January 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)