Optimal Number of Pleural Biopsies During Pleuroscopy

NCT ID: NCT06897878

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-05

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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After enrollment, participants will undergo pleural biopsies via pleuroscopy. Specimens will be divided into three aliquots (1-3, 4-6, 7-10), which will be sent to pathology. A designated pathologist will evaluate the specimens in each aliquot to determine the number of biopsies required to reach a diagnosis and to obtain sufficient material for biomarker testing (when needed), and determine whether analysis of further aliquots is needed.

Conditions

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Pleural Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pleural biopsy

All consecutive patients referred for a pleuroscopy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- Inability to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Udit Chaddha

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Udit Chaddha

Role: PRINCIPAL_INVESTIGATOR

MBBS

Locations

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Mount Sinai Hospital

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeeyune Bahk, MBBS BSc

Role: CONTACT

7186836791

Facility Contacts

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Jeeyune Bahk, MBBS BSc

Role: primary

7186836791

Axel Duval, MD

Role: backup

Other Identifiers

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STUDY-24-01325

Identifier Type: -

Identifier Source: org_study_id

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