Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316134
Status:
TERMINATED
Last Update Posted:
2011-11-08
First Post:
2006-04-18
Brief Title:
Multiple Biomarkers in Undiagnosed Pleural Effusion
Sponsor:
Fujirebio Diagnostics Inc
Organization:
Fujirebio Diagnostics Inc
Study Overview
Official Title:
Evaluation of Multiple Biomarkers in Serum and Pleural Fluid to Estimate the Probability of Cancer in Patients Presenting With an Undiagnosed Pleural Effusion
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated on completion of the Pilot Study phase
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to evaluate the ability of various biomarkers measured in serum andor pleural fluids to estimate the risk of finding cancer in patients with undiagnosed pleural effusions An algorithm for prediction of the risk of finding cancer in the patient using an optimal combination of markers will be developed and patients will be categorized as having a low moderate or high risk of finding cancer that might be used to more effectively triage patients
Detailed Description:
Approximately 16 million cases of pleural effusion are seen in the US per year with 210000 of those cases due to underlying malignancy Pleural fluids have traditionally been divided into two types transudative and exudative The most common causes of transudative pleural effusion are congestive heart failure and cirrhosis Common causes of exudative pleural effusion include malignancy pneumonia pulmonary embolism and viral infection One study found that 42 of all exudative effusions were due to malignancy and another found that malignancy was the underlying cause of 24 of all effusions Differential diagnosis of the various causes of effusions is complex and includes gross appearance of the pleural fluid PF differential cell count cytology glucose and LDH levels and sometimes adenosine deaminase ADA levels In addition spiral CT scans bronchoscopy thoracoscopy needle biopsy of the pleura and video assisted thoracoscopy VATS are all utilized to determine the underlying cause of pleural fluid accumulation These procedures are expensive and may be traumatic to patients In approximately 20 of patients presenting with pleural fluid accumulation no underlying cause will be established Despite promising results published in peer-reviewed journals over the last two decades serum biomarkers have not gained acceptance as a standard of care in the management of patients with lung cancer mesothelioma or pleural effusion The purpose of this clinical trial is to evaluate the ability of various biomarkers measured in serum andor pleural fluids to estimate the risk of finding cancer in patients with undiagnosed pleural effusions An algorithm for prediction of the risk of finding cancer in the patient using an optimal combination of markers will be developed and patients will be categorized as having a low moderate or high risk of finding cancer that might be used to more effectively triage patients For example a high risk of cancer may be used to justify more invasive or expensive procedures such as spiral CT scans and thoracoscopy
This is a prospective multi-center double-blind statistically powered clinical trial that will enroll patients scheduled to undergo a procedure for removal of fluid from a pleural effusion ie thoracentesis thoracoscopy image guided thoracentesis thoracotomy chest tube placement Pleurex catheter insertion etc
The primary objective of the study is to evaluate the ability of multiple biomarkers in serum andor pleural fluid to estimate the risk of finding cancer in subjects presenting with an undiagnosed pleural effusion ie unknown origin
The secondary objective of the study is to compare the ability of multiple biomarkers in serum andor pleural fluid combined with pleural fluid cytology and other laboratory results to the use of the multiple biomarkers alone to estimate the risk of finding cancer in subjects presenting with an undiagnosed pleural effusion
The research objectives of the study are the evaluation of the utility of multiple biomarkers in serum andor pleural fluid to predict the tissue of origin in subjects with cancer who presented with an undiagnosed pleural effusion and comparison of these results to pleural fluid cytology Correlation of the biomarker levels in the serum and pleural fluid will be evaluated as well
This is a prospective multi-center double-blind statistically powered clinical trial that will enroll patients scheduled to undergo a procedure for removal of fluid from a pleural effusion ie thoracentesis thoracoscopy image guided thoracentesis thoracotomy chest tube placement Pleurex catheter insertion etc
The primary objective of the study is to evaluate the ability of multiple biomarkers in serum andor pleural fluid to estimate the risk of finding cancer in subjects presenting with an undiagnosed pleural effusion ie unknown origin
The secondary objective of the study is to compare the ability of multiple biomarkers in serum andor pleural fluid combined with pleural fluid cytology and other laboratory results to the use of the multiple biomarkers alone to estimate the risk of finding cancer in subjects presenting with an undiagnosed pleural effusion
The research objectives of the study are the evaluation of the utility of multiple biomarkers in serum andor pleural fluid to predict the tissue of origin in subjects with cancer who presented with an undiagnosed pleural effusion and comparison of these results to pleural fluid cytology Correlation of the biomarker levels in the serum and pleural fluid will be evaluated as well
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None