Rapid On Site Evaluation of Pleural Touch Preparations in Diagnosing Malignant Pleural Effusion in Patients Undergoing Pleuroscopy

NCT ID: NCT03868579

Last Updated: 2025-03-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2025-02-27

Brief Summary

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This trial studies how well rapid on site evaluation of pleural touch preparations works in diagnosing cancerous fluid in between the linings of the lungs (malignant pleural effusion) in patients undergoing a pleuroscopy. A type of laboratory testing called rapid on site evaluation of pleural touch preparations that uses pleural biopsy tissue samples collected during an already-scheduled pleuroscopy may be able to diagnose malignant pleural effusion.

Detailed Description

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PRIMARY OBJECTIVES:

I. To estimate the specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy.

SECONDARY OBJECTIVES:

I. To estimate the sensitivity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy.

II. To estimate the specificity and sensitivity of visual assessment of pleura for predicting malignancy on final pathology in pleuroscopy.

III. To compare the specificity and sensitivity of ROSE of touch preps between centers.

OUTLINE:

Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.

Conditions

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Malignant Neoplasm Malignant Respiratory Tract Neoplasm Malignant Thoracic Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Observational (pleuroscopy, medical chart review)

Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.

Group Type EXPERIMENTAL

Biopsy

Intervention Type PROCEDURE

Undergo biopsy

Medical Chart Review

Intervention Type OTHER

Review medical chart

Thoracoscopy

Intervention Type PROCEDURE

Undergo pleuroscopy

Interventions

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Biopsy

Undergo biopsy

Intervention Type PROCEDURE

Medical Chart Review

Review medical chart

Intervention Type OTHER

Thoracoscopy

Undergo pleuroscopy

Intervention Type PROCEDURE

Other Intervention Names

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Bx Chart Review

Eligibility Criteria

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Inclusion Criteria

* Patients who will undergo pleuroscopy with biopsy

Exclusion Criteria

* Patients with known malignant pleural effusion
* Inability or unwillingness to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Horiana Grosu

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Nicosia General Hospital

Nicosia, , Cyprus

Site Status

Countries

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United States Cyprus

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2019-00735

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-0746

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0746

Identifier Type: -

Identifier Source: org_study_id

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