Pulmonary NoduleNCT00917137
Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy
An observational study of Pulmonary Nodule and Pulmonary Mass, run by Maggiore Bellaria Hospital, Bologna at 1 site in Italy.
Trial summary
The main purposes of this study are to assess the performance characteristics of transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, and to identify the predictor variables of a positive aspirate. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Pulmonary Nodule, Pulmonary Mass
- What is being tested?
- TBNA + transbronchial lung biopsy + bronchial washing
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2008to Jun 2010
- 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 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with pulmonary nodule or mass referred for bronchoscopy to the Thoracic Endoscopy Unit of Maggiore Hospital (Bologna Italy)
Who may be able to join
- Age 18 years and older
- Pulmonary nodule (< 3 cm) or mass (> 3 cm) at computed tomography
Who cannot join
- Refusal to sign informed consent
- Uncontrolled coagulopathy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy: Yield and Predictors of a Positive Aspirate
The main purposes of this study are to assess the performance characteristics of transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, and to identify the predictor variables of a positive aspirate.
Read the detailed description
In a recent systematic literature review (Rivera PM, Mehta AC; Chest 2007; 132: 1318-1488) TBNA showed the highest sensitivity in the diagnostic bronchoscopic approach to peripheral pulmonary lesions, as compared to the other available sampling techniques (transbronchial biopsy, brushing, washings). However, the Authors conclude that the data regarding TBNA in this setting deserve cautious interpretation because of the limited number of studies and the large differences in sample size). We designed the present study to assess the performance characteristics of TBNA, alone and in comparison with those of transbronchial biopsy, in the diagnosis of peripheral pulmonary lesions.
- Conditions
- Pulmonary Nodule, Pulmonary Mass
- Being tested
- TBNA + transbronchial lung biopsy + bronchial washing
- Keywords
- Lung cancer, Lung nodule, Transbronchial needle aspiration, Transbronchial lung biopsy, Bronchoscopy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBNA + transbronchial lung biopsy + bronchial washingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Peripheral pulmonary lesions | Not described Receives: Procedure: TBNA + transbronchial lung biopsy + bronchial washing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions
Measured: 1 year
Secondary outcomes (2)
Evaluate the predictor variables associated with a positive TBNA result
Measured: 1 year
Compare the performance characteristics of TBNA and transbronchial lung biopsy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJul 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NoduleStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maggiore Bellaria Hospital, Bologna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917137
- Sponsor's protocol ID
- 02-Trisolini
- Status last verified
- Jun 2010
- First submitted
- 9 Jun 2009
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy: Yield and Predictors of a Positive Aspirate
- ClinicalTrials.gov ID
- NCT00917137
- Acronym / sponsor ID
- 02-Trisolini
- Conditions
- Pulmonary Nodule, Pulmonary Mass
- Keywords
- Lung cancer, Lung nodule, Transbronchial needle aspiration, Transbronchial lung biopsy, Bronchoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Maggiore Bellaria Hospital, BolognaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 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 main purposes of this study are to assess the performance characteristics of transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, and to identify the predictor variables of a positive aspirate.
Detailed description
In a recent systematic literature review (Rivera PM, Mehta AC; Chest 2007; 132: 1318-1488) TBNA showed the highest sensitivity in the diagnostic bronchoscopic approach to peripheral pulmonary lesions, as compared to the other available sampling techniques (transbronchial biopsy, brushing, washings). However, the Authors conclude that the data regarding TBNA in this setting deserve cautious interpretation because of the limited number of studies and the large differences in sample size). We designed the present study to assess the performance characteristics of TBNA, alone and in comparison with those of transbronchial biopsy, in the diagnosis of peripheral pulmonary lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral pulmonary lesions | – | Procedure: TBNA + transbronchial lung biopsy + bronchial washing |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with pulmonary nodule or mass referred for bronchoscopy to the Thoracic Endoscopy Unit of Maggiore Hospital (Bologna Italy)
Key inclusion criteria (2 listed)
- Age 18 years and older
- Pulmonary nodule (< 3 cm) or mass (> 3 cm) at computed tomography
Key exclusion criteria (3 listed)
- Refusal to sign informed consent
- Uncontrolled coagulopathy
- 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 |
|---|---|---|
| TBNA + transbronchial lung biopsy + bronchial washing | Procedure or surgery | Peripheral pulmonary lesions |
Primary outcome
Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions
Time frame: 1 year
2 secondary outcomes
Evaluate the predictor variables associated with a positive TBNA result
Time frame: 1 year
Compare the performance characteristics of TBNA and transbronchial lung biopsy
Time frame: 1 year
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 23 Jun 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodule and Pulmonary Mass, 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 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 23 Jun 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?
Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions (time frame: 1 year). 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 23 Jun 2010.