Multiple Biomarkers in Undiagnosed Pleural Effusion

Stopped early

Conditions studied: Pleural Effusion, Pleural Effusion, Malignant

In brief

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 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.

Key facts

Study ID

NCT00316134

Run by

Fujirebio Diagnostics, Inc.

People needed

200

Starts

2006-03-01

Expected to finish

2008-02-01

Last updated by the study team

2011-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Fujirebio Diagnostics, Inc — Malvern, Pennsylvania, United States

Full record on ClinicalTrials.gov

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