Lung CancerNCT03845764
Can a Pulmonologist Reliably Assess the Tumor Burden on ROSE Slides Obtained From Pulmonary Nodules and Lymphadenopathy
An observational study of Lung Cancer, run by Maggiore Bellaria Hospital, Bologna at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Rapid on-site evaluation
- How many people
- 164 participants
- Where
- 2 sitesItaly
- Study dates
- 18 Feb 2019to 30 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with indication to bronchoscopy or endosonography for suspected lung cancer based on imaging (CT and/or PET)
Who may be able to join
- Age > 18 years
- Indication for endoscopic sampling of suspected malignant lymphadenopathy or pulmonary lesion
- Written informed consent
Who cannot join
- High risk conditions for the performance of bronchoscopy and/or EBUS-TBNA
- High risk condition for deep sedation (ASA 4)
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Maggiore Hospital
Bologna, Emilia-Romagna, 40133
Policlinico S. Orsola
Bologna
About this study
Official title: Interobserver Agreement Between Pulmonologist, Pathologist and Molecular Pathologist in the Assessment of Tumor Burden on ROSE Slides Obtained With Endoscopic Procedures From Pulmonary Nodules and Intrathoracic Lymphadenopathy
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.
- Conditions
- Lung Cancer
- Being tested
- Rapid on-site evaluation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid on-site evaluationDiagnostic test
Specimens obtained with endoscopic sampling procedures are stained with a rapid method (i.e., Diff Qui) and submitted to on-site cytologic review
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Rapid on-site evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy with which a pulmonologist can assess the tumor burden on ROSE slides
The outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the molecular pathologist judgment, the latter being the gold standard
Measured: The time frame is the duration of each bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled
Secondary outcomes (2)
Interobserver agreement between pulmonologist, pathologist and molecular pathologist in then assessment of the tumor burden on ROSE slides
The outcome 2 will be measured by verifying the agreement between the 3 professionals, using the judgment of the molecular pathologist as gold standard
Measured: The time frame is the duration of each bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled
Accuracy with which a pulmonologist can identify malignancy on ROSE samples
The outcome 3 will be measured by verifying the agreement between pulmonologist and pathologist, the latter being the gold standard
Measured: The time frame is the duration of each bronchoscopy endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start18 Feb 2019
- Primary completion30 Jun 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maggiore Bellaria Hospital, Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocco Trisolini, Maggiore Bellaria Hospital, Bologna
- Investigators
- Rocco Trisolini, MD, Principal investigator, Policlinico S. Orsola, Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845764
- Sponsor's protocol ID
- Bio-Pulmo-ROSE
- Status last verified
- Aug 2019
- First submitted
- 16 Feb 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interobserver Agreement Between Pulmonologist, Pathologist and Molecular Pathologist in the Assessment of Tumor Burden on ROSE Slides Obtained With Endoscopic Procedures From Pulmonary Nodules and Intrathoracic Lymphadenopathy
- ClinicalTrials.gov ID
- NCT03845764
- Acronym / sponsor ID
- Bio-Pulmo-ROSE
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Maggiore Bellaria Hospital, BolognaUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid on-site evaluation (ROSE) | – | Diagnostic Test: Rapid on-site evaluationEvaluation, 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with indication to bronchoscopy or endosonography for suspected lung cancer based on imaging (CT and/or PET)
Key inclusion criteria (3 listed)
- Age > 18 years
- Indication for endoscopic sampling of suspected malignant lymphadenopathy or pulmonary lesion
- Written informed consent
Key exclusion criteria (3 listed)
- High risk conditions for the performance of bronchoscopy and/or EBUS-TBNA
- High risk condition for deep sedation (ASA 4)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid on-site evaluationSpecimens obtained with endoscopic sampling procedures are stained with a rapid method (i.e., Diff Qui) and submitted to on-site cytologic review | Diagnostic test | Rapid on-site evaluation (ROSE) |
Primary outcome
Accuracy with which a pulmonologist can assess the tumor burden on ROSE slides
Time frame: The time frame is the duration of each bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled
The outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the molecular pathologist judgment, the latter being the gold standard
2 secondary outcomes
Interobserver agreement between pulmonologist, pathologist and molecular pathologist in then assessment of the tumor burden on ROSE slides
Time frame: The time frame is the duration of each bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled
Accuracy with which a pulmonologist can identify malignancy on ROSE samples
Time frame: The time frame is the duration of each bronchoscopy endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocco Trisolini, MD principal investigator
Policlinico S. Orsola, Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Maggiore Bellaria Hospital, Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy with which a pulmonologist can assess the tumor burden on ROSE slides (time frame: The time frame is the duration of each bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.