NCT06897878

Brief Summary

A single-center, non-randomized, prospective observational, pilot study designed to determine what is the optimal number of pleural biopsies to take during pleuroscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2025

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

March 20, 2025

Last Update Submit

February 2, 2026

Conditions

Pleural Diseases

Keywords

PleuroscopyPleural effusionPleural biopsy

Outcome Measures

Primary Outcomes (1)

  • Number of pleural biopsies to reach a diagnosis

    The number of pleural biopsies needed to reach a diagnosis.

    At week 2 after pleuroscopy

Secondary Outcomes (2)

  • Number of pleural biopsies required for comprehensive biomarker testing.

    At week 4 after pleuroscopy

  • Number of complications

    At week 4 after pleuroscopy

Study Arms (1)

Pleural biopsy

All consecutive patients referred for a pleuroscopy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients that undergo pleuroscopy for pleural biopsies, excluding those with inability to provide informed consent.

You may qualify if:

  • Consecutive patients who require pleuroscopies will be enrolled to the study.
  • Age ≥ 18

You may not qualify if:

  • \- Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10028, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pleural tissues from pleural biopsies that will be analyzed in the pathology lab.

MeSH Terms

Conditions

Pleural DiseasesPleural Effusion

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Udit Chaddha

    MBBS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 20, 2025

First Posted

March 27, 2025

Study Start

December 5, 2024

Primary Completion

December 18, 2025

Study Completion

December 18, 2025

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Immediately following publication. No end date.
Access Criteria
Anyone who wishes to access the data. Any purpose. Proposals should be directed to jeeyune.bahk@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.

Locations

US(1)