NCT03868579

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

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

January 10, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2025

Completed
Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

7.1 years

First QC Date

March 7, 2019

Last Update Submit

February 28, 2025

Conditions

Malignant NeoplasmMalignant Respiratory Tract NeoplasmMalignant Thoracic Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy

    Descriptive statistics (e.g., frequencies, ranges, means, medians, proportions, and standard deviations \[SDs\]) along with 95% confidence intervals (CIs) for the means or proportions will be computed for the measures of interest. Specificity will be defined as true negative (TN) divided by (TN + false positive \[FP\]). High probability of malignancy is defined as adequate tissue with tumor present. Low probability of malignancy defined is adequate tissue with no tumor present. Indeterminate probability of malignancy is defined as presence of atypical cells but inadequate for a definitive diagnosis on ROSE. Will collapse the indeterminate probability of malignancy (atypical cells category) found on touch preps into low probability for malignancy bin and indeterminate probability of malignancy on visual assessment into low probability for malignancy.

    Up to 1 year

Secondary Outcomes (7)

  • Sensitivity of ROSE of preps for predicting malignancy

    Up to 1 year

  • Specificity of visual assessment of pleura for predicting malignancy

    Up to 1 year

  • Sensitivity of visual assessment of pleura for predicting malignancy

    Up to 1 year

  • Positive predictive value (PPV) for all patients

    Up to 1 year

  • Negative predictive value (NPV) for all patients

    Up to 1 year

  • +2 more secondary outcomes

Study Arms (1)

Observational (pleuroscopy, medical chart review)

EXPERIMENTAL

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

Procedure: BiopsyOther: Medical Chart ReviewProcedure: Thoracoscopy

Interventions

BiopsyPROCEDURE

Undergo biopsy

Also known as: Bx
Observational (pleuroscopy, medical chart review)
Medical Chart ReviewOTHER

Review medical chart

Also known as: Chart Review
Observational (pleuroscopy, medical chart review)
ThoracoscopyPROCEDURE

Undergo pleuroscopy

Observational (pleuroscopy, medical chart review)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will undergo pleuroscopy with biopsy

You may not qualify if:

  • Patients with known malignant pleural effusion
  • Inability or unwillingness to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Nicosia General Hospital

Nicosia, Cyprus

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

BiopsyThoracoscopy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesEndoscopyMinimally Invasive Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Horiana Grosu

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 11, 2019

Study Start

January 10, 2018

Primary Completion

February 27, 2025

Study Completion

February 27, 2025

Last Updated

March 5, 2025

Record last verified: 2025-02

Locations

US(3)CY(1)