Can a Pulmonologist Reliably Assess the Tumor Burden on ROSE Slides Obtained From Pulmonary Nodules and Lymphadenopathy

NCT ID: NCT03845764

Last Updated: 2019-08-15

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

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-18

Study Completion Date

2019-07-30

Brief Summary

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The study is aimed at verifying if a pulmonologist can reliably assess the tumor burden for the extractive molecular analysis in ROSE samples obtained with endoscopic sampling procedures from intrathoracic lymphadenopathy and pulmonary nodules.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rapid on-site evaluation (ROSE)

Evaluation, made by a pulmonologist, a pathologist and a molecular pathologist, of the tumor burden in ROSE slides produced from endoscopic procedures aimed at sampling intrathoracic lymphadenopathy and pulmonary nodules

Rapid on-site evaluation

Intervention Type DIAGNOSTIC_TEST

Specimens obtained with endoscopic sampling procedures are stained with a rapid method (i.e., Diff Qui) and submitted to on-site cytologic review

Interventions

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Rapid on-site evaluation

Specimens obtained with endoscopic sampling procedures are stained with a rapid method (i.e., Diff Qui) and submitted to on-site cytologic review

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Indication for endoscopic sampling of suspected malignant lymphadenopathy or pulmonary lesion
* Written informed consent

Exclusion Criteria

* High risk conditions for the performance of bronchoscopy and/or EBUS-TBNA
* High risk condition for deep sedation (ASA 4)
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maggiore Bellaria Hospital, Bologna

OTHER

Sponsor Role lead

Responsible Party

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Rocco Trisolini

Director, Interventional Pulmonology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rocco Trisolini, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico S. Orsola, Bologna

Locations

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Maggiore Hospital

Bologna, Emilia-Romagna, Italy

Site Status

Policlinico S. Orsola

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Bio-Pulmo-ROSE

Identifier Type: -

Identifier Source: org_study_id

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