Status:
TERMINATED
Multiple Biomarkers in Undiagnosed Pleural Effusion
Lead Sponsor:
Fujirebio Diagnostics, Inc.
Conditions:
Pleural Effusion
Pleural Effusion, Malignant
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this clinical trial is to evaluate the ability of various biomarkers measured in serum and/or pleural fluids to estimate the risk of finding cancer in patients with undiagnosed pleural ...
Detailed Description
Approximately 1.6 million cases of pleural effusion are seen in the US per year, with \~210,000 of those cases due to underlying malignancy. Pleural fluids have traditionally been divided into two typ...
Eligibility Criteria
Inclusion
- TRAINING SET INCLUSION CRITERIA
- Subjects able to understand and sign Informed Consent;
- Males or females \>18 years of age;
- Have a pleural effusion of known or unknown origin;
- Scheduled for a diagnostic and/or therapeutic procedure to remove pleural fluid.
- VALIDATION SET INCLUSION CRITERIA
- Subjects able to understand and sign Informed Consent;
- Males or females \>18 years of age;
- Have a pleural effusion of unknown origin;
- Scheduled for a diagnostic procedure to remove pleural fluid.
Exclusion
- TRAINING SET EXCLUSION CRITERIA
- For Subjects currently receiving chemotherapy and/or radiation therapy- Subjects who have received chemotherapy and/or radiation therapy must have completed these modalities one month before entering the study.
- Females known to be pregnant;
- Already entered into the study;
- Unable or unwilling to provide informed consent or is there a high risk that the subject may not comply with the protocol requirements
- VALIDATION SET EXCLUSION CRITERIA
- For Subjects currently receiving chemotherapy and/or radiation therapy- Subjects who have received chemotherapy and/or radiation therapy must have completed these modalities one month before entering the study.
- Females known to be pregnant;
- Already entered into the study;
- Unable or unwilling to provide informed consent or is there a high risk that the subject may not comply with the protocol requirements
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00316134
Start Date
March 1 2006
End Date
February 1 2008
Last Update
November 8 2011
Active Locations (1)
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1
Fujirebio Diagnostics, Inc
Malvern, Pennsylvania, United States, 19355