Clinical trial: Multiple Biomarkers in Undiagnosed Pleural Effusion (NCT00316134)

Eligibility criteria:
Inclusion Criteria:

        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 Criteria:

        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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? Entailment