NCT07039019 · Icahn School of Medicine at Mount Sinai
Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis
(PROSPECT)
What this study is about
This research study aims to evaluate whether corticosteroids help prevent the recurrence of pleural effusions in patients with non-specific pleuritis diagnosed through pleural biopsy. It can lead to recurrent fluid buildup in the lungs, causing discomfort and requiring additional medical interventions.
View original scientific description
This research study aims to evaluate whether corticosteroids help prevent the recurrence of pleural effusions in patients with non-specific pleuritis diagnosed through pleural biopsy. It can lead to recurrent fluid buildup in the lungs, causing discomfort and requiring additional medical interventions. There is no established treatment to prevent recurrence, and this study seeks to determine whether steroids reduce fluid buildup or cause complications. There will be two groups: one receiving corticosteroids (standard of care in the institution) and one not receiving corticosteroids (intervention group). The participation will last approximately 6 months, with in-person visits every 2 weeks for the first month, then monthly, along with possible telephone follow-ups. The study will monitor for pleural effusion recurrence, need for additional procedures, and potential side effects of corticosteroids. This is a pilot study. Although there are forty people expected to take part in this research study based on institutional data, the number of patients included in the study will be determined by the number of patients with non-specific pleuritis diagnosed during the study period.
Interventions
DRUG
Corticosteroid
Patients take 40 mg of prednisone daily for 4 weeks to help reduce inflammation.
OTHER
No Corticosteroid
Patients do not take corticosteroid.
Primary outcome measures
Number of patients screened
Time frame: every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months
Screened defined as how many patients are evaluated for participation
Number of patients enrolled
Time frame: every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months
Enrolled defined as how many screened patients actually join the study
Number of patients retained
Time frame: every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months
Retention defined as how many enrolled patients continue participating over time
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- All adult patients with diagnosis of non-specific pleuritis as determined by pleural biopsy with a negative serologic autoimmune profile (ANA, ANCA, anti-DS DNA, anti-SS A/B, anti-centromere, RF, anti-CCP) are eligible
Exclusion criteria
- Chronic/fibrinous pleuritis
- Positive autoimmune serologic workup
- A contraindication to corticosteroids
- Patients already receiving corticosteroids or other immunosuppressive medications for any other indication
- Inability to obtain informed consent due to cognitive, neurologic or psychiatric impairment
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations