RECRUITING

Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Pilot, RandOmized Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis

Quick Facts

Study Start:2025-06-04
Study Completion:2026-11-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07039019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  1. * Chronic/fibrinous pleuritis
  2. * Positive autoimmune serologic workup
  3. * A contraindication to corticosteroids
  4. * Empyema
  5. * Patients already receiving corticosteroids or other immunosuppressive medications for any other indication
  6. * Inability to obtain informed consent due to cognitive, neurologic or psychiatric impairment

Contacts and Locations

Study Contact

Axel Duval, MD
CONTACT
212-824-8546
axel.duval@mountsinai.org

Principal Investigator

Udit Chaddha, MBBS
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine

Study Locations (Sites)

Mount Sinai Hospital
New York, New York, 10029
United States
Mount Sinai Morningside
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Udit Chaddha, MBBS, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-04
Study Completion Date2026-11-19

Study Record Updates

Study Start Date2025-06-04
Study Completion Date2026-11-19

Terms related to this study

Additional Relevant MeSH Terms

  • Pleuritis, Non-specific