Lung CancerCT0018NCT01141946
Pleural Ultrasonography in Lung Cancer
An observational study of Lung Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Lung cancer remains the leading cause of mortality from malignant diseases in both men and women worldwide. Accurate diagnosis, staging and therapeutic targeting of lung cancer and other pulmonary pathology are vital with regards to providing patients with expedient and accurate treatment and treatment plans. 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?
- thoracic ultrasound and pleural aspiration
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Lung lesion being evaluated for surgery during initial consultation with a thoracic surgeon
Who cannot join
- Age < 18 years old
- Inability to consent for the study
- Chest wall anatomy precluding PULC
- Inability to sit upright
- Medications including Warfarin (Coumadin) or Clopidogrel (Plavix) in patient requiring pleural fluid aspiration
- Active cutaneous infection overlying proposed puncture site
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2L 4M1
About this study
Official title: Pleural Ultrasonography in Lung Cancer - PULC
Lung cancer remains the leading cause of mortality from malignant diseases in both men and women worldwide. Accurate diagnosis, staging and therapeutic targeting of lung cancer and other pulmonary pathology are vital with regards to providing patients with expedient and accurate treatment and treatment plans. The pre-operative evaluation and consultation in patients who are to undergo operative staging or resection for lung cancer is multidimensional and involves detailed history taking, physical examination and review of imaging studies. Two important elements of both staging and pre-operative evaluation include the evaluation of: (1) the pleural space for malignant pleural effusion and (2) the diaphragm for appropriate movement. At this point in time, the pleural space evaluation is being performed using CT scan which does not allow the acquisition of real-time cytological material from pleural effusions due to the fact that the CT scans are done in a diagnostic setting. Diaphragmatic movement/excursion is not currently being assessed pre-operatively and its impact on staging and post-operative pulmonary function is unknown.
Malignant pleural effusion is recognized as a poor prognosticator in non-small cell lung cancer patients and has recently been upgraded from a T4 to an M1a status in the new edition of the AJCC NSCLC Staging System (7th Edition). The appreciation of the poor prognosis related to malignant effusion has upgraded the stage from a Stage IIIb to a stage IV. Recognizing the stage early allows for more precise prognostication of disease and can lead to precision and streamlining of treatment plans for thoracic surgeons and oncologists.
Read the detailed description
Hypotheses:
- Pleural ultrasonography with evaluation, quantification and aspiration of pleural effusion allows for improved pre-operative staging and alters decision-making patterns for lung cancer patients.
- Pleural ultrasonography with evaluation of appropriate diaphragmatic respiratory movement can predict post-operative complications in patient undergoing lung cancer surgery.
Objectives:
The goals of this project within the program are to:
- Evaluate the improvement in pre-operative staging with the addition of pre-operative pleural ultrasonography for malignant pleural effusion.
- Evaluate the ability of pre-operative diaphragmatic ultrasound to predict post-operative morbidity following pulmonary surgery.
Methodology:
This study will consist of a prospective evaluation of surgeon-performed pleural and diaphragmatic ultrasound in the pre-operative evaluation of lung cancer patients. All patients being seen in the thoracic surgery pre-operative clinic with the new or presumed diagnosis of lung cancer will be approached for prospective enrolment into the study. Consented patients will undergo standard history and physical examination by the treating thoracic surgeon. During or after the physical examination, PULC will be performed by the study investigators.
Measurements will include: (1) bilateral diaphragmatic excursion during sniffing, (2) pleural fluid evaluation in bilateral costophrenic sulci. Should pleural fluid be found on the ipsilateral side to the mass (tumor), the fluid will be aspirated under sterile conditions in the clinic and sent for cytology analysis. US evaluation will be performed in the upright, supine and decubitus position.
Results will be analyzed using parametric methodology in order to ascertain the additional information gained and the change in staging (upstaging) with the addition of PULC to standard history and physical examination during the initial evaluation of thoracic surgical patients.
The study will enrol 50 patients. Recruitment will occur at the thoracic outpatient surgical clinic at the CHUM. Enrolment is expected at a level of five patients per week and therefore the study recruitment is expected to take 2.5 months.
Impact:
The potential impact of a positive trial will change the way clinicians evaluate, stage and risk stratify patients who are to undergo operative interventions for lung cancer.
- Conditions
- Lung Cancer
- Being tested
- thoracic ultrasound, pleural aspiration
- Keywords
- lung cancer, pleural effusion, post-op care, diaphragmatic ultrasound
- Medical subject headings
- Lung Neoplasms, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic ultrasoundProcedure or surgery
All patients will receive pre-operative pleural-based ultrasound during their initial consultation.
pleural aspirationProcedure or surgery
Before proceeding to pleural aspiration, a radiography of the chest will be performed in order to ascertain the presence of a pleural effusion.
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement in pre-operative staging with the addition of pre-operative pleural ultrasonography for malignant pleural effusion.
Measured: 3 months
Secondary outcomes (1)
The ability of pre-operative diaphragmatic ultrasound to predict post-operative morbidity following pulmonary surgery.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionOct 2010
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.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Society of University Surgeons
- Responsible party
- Sponsor
- Investigators
- Moishe Liberman, MD, PhD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141946
- Sponsor's protocol ID
- CE 10.046
- Acronym
- CT0018
- Status last verified
- Jun 2011
- First submitted
- 7 Jun 2010
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pleural Ultrasonography in Lung Cancer - PULC
- ClinicalTrials.gov ID
- NCT01141946
- Acronym / sponsor ID
- CT0018 / CE 10.046
- Conditions
- Lung Cancer
- Keywords
- lung cancer, pleural effusion, post-op care, diaphragmatic ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Society of University Surgeons
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Jun 2010 (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.
Lung cancer remains the leading cause of mortality from malignant diseases in both men and women worldwide. Accurate diagnosis, staging and therapeutic targeting of lung cancer and other pulmonary pathology are vital with regards to providing patients with expedient and accurate treatment and treatment plans. The pre-operative evaluation and consultation in patients who are to undergo operative staging or resection for lung cancer is multidimensional and involves detailed history taking, physical examination and review of imaging studies. Two important elements of both staging and pre-operative evaluation include the evaluation of: (1) the pleural space for malignant pleural effusion and (2) the diaphragm for appropriate movement. At this point in time, the pleural space evaluation is being performed using CT scan which does not allow the acquisition of real-time cytological material from pleural effusions due to the fact that the CT scans are done in a diagnostic setting. Diaphragmatic movement/excursion is not currently being assessed pre-operatively and its impact on staging and post-operative pulmonary function is unknown.
Malignant pleural effusion is recognized as a poor prognosticator in non-small cell lung cancer patients and has recently been upgraded from a T4 to an M1a status in the new edition of the AJCC NSCLC Staging System (7th Edition). The appreciation of the poor prognosis related to malignant effusion has upgraded the stage from a Stage IIIb to a stage IV. Recognizing the stage early allows for more precise prognostication of disease and can lead to precision and streamlining of treatment plans for thoracic surgeons and oncologists.
Detailed description
Hypotheses:
- Pleural ultrasonography with evaluation, quantification and aspiration of pleural effusion allows for improved pre-operative staging and alters decision-making patterns for lung cancer patients.
- Pleural ultrasonography with evaluation of appropriate diaphragmatic respiratory movement can predict post-operative complications in patient undergoing lung cancer surgery.
Objectives:
The goals of this project within the program are to:
- Evaluate the improvement in pre-operative staging with the addition of pre-operative pleural ultrasonography for malignant pleural effusion.
- Evaluate the ability of pre-operative diaphragmatic ultrasound to predict post-operative morbidity following pulmonary surgery.
Methodology:
This study will consist of a prospective evaluation of surgeon-performed pleural and diaphragmatic ultrasound in the pre-operative evaluation of lung cancer patients. All patients being seen in the thoracic surgery pre-operative clinic with the new or presumed diagnosis of lung cancer will be approached for prospective enrolment into the study. Consented patients will undergo standard history and physical examination by the treating thoracic surgeon. During or after the physical examination, PULC will be performed by the study investigators.
Measurements will include: (1) bilateral diaphragmatic excursion during sniffing, (2) pleural fluid evaluation in bilateral costophrenic sulci. Should pleural fluid be found on the ipsilateral side to the mass (tumor), the fluid will be aspirated under sterile conditions in the clinic and sent for cytology analysis. US evaluation will be performed in the upright, supine and decubitus position.
Results will be analyzed using parametric methodology in order to ascertain the additional information gained and the change in staging (upstaging) with the addition of PULC to standard history and physical examination during the initial evaluation of thoracic surgical patients.
The study will enrol 50 patients. Recruitment will occur at the thoracic outpatient surgical clinic at the CHUM. Enrolment is expected at a level of five patients per week and therefore the study recruitment is expected to take 2.5 months.
Impact:
The potential impact of a positive trial will change the way clinicians evaluate, stage and risk stratify patients who are to undergo operative interventions for lung cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- Lung lesion being evaluated for surgery during initial consultation with a thoracic surgeon
Key exclusion criteria (6 listed)
- Age < 18 years old
- Inability to consent for the study
- Chest wall anatomy precluding PULC
- Inability to sit upright
- Medications including Warfarin (Coumadin) or Clopidogrel (Plavix) in patient requiring pleural fluid aspiration
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 |
|---|---|---|
| thoracic ultrasoundAll patients will receive pre-operative pleural-based ultrasound during their initial consultation. | Procedure or surgery | – |
| pleural aspirationBefore proceeding to pleural aspiration, a radiography of the chest will be performed in order to ascertain the presence of a pleural effusion. | Procedure or surgery | – |
Primary outcome
The improvement in pre-operative staging with the addition of pre-operative pleural ultrasonography for malignant pleural effusion.
Time frame: 3 months
1 secondary outcome
The ability of pre-operative diaphragmatic ultrasound to predict post-operative morbidity following pulmonary surgery.
Time frame: 3 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 17 Jul 2012.
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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.
Moishe Liberman, MD, PhD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
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 Lung Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 1 inclusion and 6 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 17 Jul 2012. 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 Canada. 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?
The improvement in pre-operative staging with the addition of pre-operative pleural ultrasonography for malignant pleural effusion. (time frame: 3 months). 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 17 Jul 2012.