Lung CancerNCT00915330
Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy
A study testing Rapid on-site cytopathologic evaluation (ROSE) and TBNA in people with Lung Cancer and Sarcoidosis, run by Maggiore Bellaria Hospital, Bologna at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether rapid on-site cytopathologic evaluation (ROSE) can increase the diagnostic yield of transbronchial needle aspiration (TBNA) in the diagnosis of hilar and mediastinal lymphadenopathy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer, Sarcoidosis, Tuberculosis
- What is being tested?
- Rapid on-site cytopathologic evaluation (ROSE) and TBNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteItaly
- Study dates
- May 2009to Feb 2010
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and older
- Hilar and/or mediastinal lymphadenopathy (> 1 cm on the short axis, as assessed by contrast-enhanced CT scan (computed tomography))
Who cannot join
- Uncontrolled coagulopathy
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transbronchial Needle Aspiration With and Without Rapid On-site Cytopathologic Evaluation in the Diagnostic Approach to Hilar/Mediastinal Adenopathy: A Randomized Controlled Trial.
The purpose of this study is to determine whether rapid on-site cytopathologic evaluation (ROSE) can increase the diagnostic yield of transbronchial needle aspiration (TBNA) in the diagnosis of hilar and mediastinal lymphadenopathy.
- Conditions
- Lung Cancer, Sarcoidosis, Tuberculosis
- Being tested
- Rapid on-site cytopathologic evaluation (ROSE), TBNA
- Keywords
- Transbronchial needle aspiration, Bronchoscopy, Rapid on-site cytopathologic evaluation, Mediastinal lymphadenopathy, Hilar Lymphadenopathy
- Medical subject headings
- Lung Neoplasms, Sarcoidosis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid on-site cytopathologic evaluation (ROSE)Procedure or surgery
ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration.
TBNAProcedure or surgery
transbronchial needle aspiration
| Study group | Role | What they receive |
|---|---|---|
| TBNA alone | Active comparator | Arm A: TBNA alone. Receives: Procedure: TBNA |
| TBNA with ROSE | Experimental | Arm B: TBNA with ROSE. Receives: Procedure: Rapid on-site cytopathologic evaluation (ROSE); Procedure: TBNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm
Measured: 6-12 months
Secondary outcomes (3)
Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm
Measured: 6-12 months
Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm
Measured: 6-12 months
Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 164 participants
Sponsor and investigators
- Lead sponsor
- Maggiore Bellaria Hospital, Bologna
- Sponsor type
- University, hospital or other
- Investigators
- Marco Patelli, MD, Principal investigator, Maggiore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915330
- Sponsor's protocol ID
- 01-Trisolini
- Status last verified
- Feb 2010
- First submitted
- 4 Jun 2009
- Last updated
- 19 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Diacon AH, Schuurmans MM, Theron J, Louw M, Wright CA, Brundyn K, Bolliger CT. Utility of rapid on-site evaluation of transbronchial needle aspirates. Respiration. 2005 Mar-Apr;72(2):182-8. doi: 10.1159/000084050.
PubMed 15824529Davenport RD. Rapid on-site evaluation of transbronchial aspirates. Chest. 1990 Jul;98(1):59-61. doi: 10.1378/chest.98.1.59.
PubMed 2361413Baram D, Garcia RB, Richman PS. Impact of rapid on-site cytologic evaluation during transbronchial needle aspiration. Chest. 2005 Aug;128(2):869-75. doi: 10.1378/chest.128.2.869.
PubMed 16100180Diette GB, White P Jr, Terry P, Jenckes M, Rosenthal D, Rubin HR. Utility of on-site cytopathology assessment for bronchoscopic evaluation of lung masses and adenopathy. Chest. 2000 Apr;117(4):1186-90. doi: 10.1378/chest.117.4.1186.
PubMed 10767258Trisolini R, Cancellieri A, Tinelli C, Paioli D, Scudeller L, Casadei GP, Forti Parri S, Livi V, Bondi A, Boaron M, Patelli M. Rapid on-site evaluation of transbronchial aspirates in the diagnosis of hilar and mediastinal adenopathy: a randomized trial. Chest. 2011 Feb;139(2):395-401. doi: 10.1378/chest.10-1521. Epub 2010 Oct 28.
PubMed 21030491
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transbronchial Needle Aspiration With and Without Rapid On-site Cytopathologic Evaluation in the Diagnostic Approach to Hilar/Mediastinal Adenopathy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00915330
- Acronym / sponsor ID
- 01-Trisolini
- Conditions
- Lung Cancer, Sarcoidosis, Tuberculosis
- Keywords
- Transbronchial needle aspiration, Bronchoscopy, Rapid on-site cytopathologic evaluation, Mediastinal lymphadenopathy, Hilar Lymphadenopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants
- Lead sponsor
- Maggiore Bellaria Hospital, BolognaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 8 Jun 2009 (estimated)
- 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 purpose of this study is to determine whether rapid on-site cytopathologic evaluation (ROSE) can increase the diagnostic yield of transbronchial needle aspiration (TBNA) in the diagnosis of hilar and mediastinal lymphadenopathy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBNA alone | Active comparator | Procedure: TBNAArm A: TBNA alone. |
| TBNA with ROSE | Experimental | Procedure: Rapid on-site cytopathologic evaluation (ROSE), Procedure: TBNAArm B: TBNA with ROSE. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old and older
- Hilar and/or mediastinal lymphadenopathy (> 1 cm on the short axis, as assessed by contrast-enhanced CT scan (computed tomography))
Key exclusion criteria (2 listed)
- Uncontrolled coagulopathy
- Refusal to sign informed consent
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 cytopathologic evaluation (ROSE)ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration. | Procedure or surgery | TBNA with ROSE |
| TBNAtransbronchial needle aspiration | Procedure or surgery | TBNA alone, TBNA with ROSE |
Primary outcome
Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm
Time frame: 6-12 months
3 secondary outcomes
Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm
Time frame: 6-12 months
Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm
Time frame: 6-12 months
Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm
Time frame: 6-12 months
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 19 Feb 2010.
- Results publication: PubMed 15824529Diacon AH, Schuurmans MM, Theron J, Louw M, Wright CA, Brundyn K, Bolliger CT. Utility of rapid on-site evaluation of transbronchial needle aspirates. Respiration. 2005 Mar-Apr;72(2):182-8. doi: 10.1159/000084050.
- Results publication: PubMed 2361413Davenport RD. Rapid on-site evaluation of transbronchial aspirates. Chest. 1990 Jul;98(1):59-61. doi: 10.1378/chest.98.1.59.
- Results publication: PubMed 16100180Baram D, Garcia RB, Richman PS. Impact of rapid on-site cytologic evaluation during transbronchial needle aspiration. Chest. 2005 Aug;128(2):869-75. doi: 10.1378/chest.128.2.869.
- Results publication: PubMed 10767258Diette GB, White P Jr, Terry P, Jenckes M, Rosenthal D, Rubin HR. Utility of on-site cytopathology assessment for bronchoscopic evaluation of lung masses and adenopathy. Chest. 2000 Apr;117(4):1186-90. doi: 10.1378/chest.117.4.1186.
- Derived from this study: PubMed 21030491Trisolini R, Cancellieri A, Tinelli C, Paioli D, Scudeller L, Casadei GP, Forti Parri S, Livi V, Bondi A, Boaron M, Patelli M. Rapid on-site evaluation of transbronchial aspirates in the diagnosis of hilar and mediastinal adenopathy: a randomized trial. Chest. 2011 Feb;139(2):395-401. doi: 10.1378/chest.10-1521. Epub 2010 Oct 28.
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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.
Marco Patelli, MD principal investigator
Maggiore Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid on-site cytopathologic evaluation (ROSE) and TBNA in people with Lung Cancer and Sarcoidosis, run by Maggiore Bellaria Hospital, Bologna at 1 site 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 2 inclusion and 2 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 19 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00915330, which also lists 5 linked publications.
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 19 Feb 2010.