Lung CancerBAT-SCANNCT01887769
Body Composition Analysis for Patient With Lung Cancer Using Computed Tomography Image Analysis
An observational study of Lung Cancer, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
Trial summary
Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Lung Cancer
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Oct 2017
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients, at diagnosis, following in oncology clinic
Who may be able to join
- Men or women
- Between 40-80 years of age
- Primary lung cancer diagnosed between 2009 and 2012
- CT-Scan done at the time of the diagnosis
Who cannot join
- Chemotherapy, radiotherapy or surgery at the time of the first Ct-Scan image
- History of other cancer (during the last five years)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
Didier Saey, PhD, 418-656-8711 ext. 2614, didier.saey@criucpq.ulaval.ca
Didier Saey, PhD
About this study
Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. However, despite the importance of cachexia in lung cancer, it has been mainly studied from several assessment methods which do not usually differentiate muscle from other tissues.
Aim: To analyze body composition of patients with lung cancer at diagnosis using computed tomography (CT-Scan) image analysis.
Methods: This is a retrospective study extending over a period of 3 years conducted at the Institut universitaire de cardiologie et de pneumologie de Québec (2009-2012). We listed patients newly diagnosed with lung cancer who had a thoraco-abdominal CT-scan performed in our institution. Following the collection of clinical data from patient records, we used SliceOmatic software to quantify muscle area, visceral fat area and subcutaneous fat area from a single abdominal cross-sectional image at the level of the third lumbar vertebra.
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Body composition analysis, Ct-Scan, Muscle mass, Cachexia
- Medical subject headings
- Lung Neoplasms, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer patient at diagnosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of muscle area (cm2/m2) at the level of the third lumbar vertebra
Measured: at the time of the diagnosis of lung cancer and one year following it.
Change of fat area (cm2/m2) at the level of the third lumbar vertebra
Measured: at the time of the diagnosis of lung cancer and one year following it.
Secondary outcomes (1)
days of survival
Measured: From the time of the diagnosis of lung cancer until one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startMay 2012
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Investigators
- Didier Saey, PhD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887769
- Sponsor's protocol ID
- 20824
- Acronym
- BAT-SCAN
- Status last verified
- Jan 2017
- First submitted
- 13 Feb 2013
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition Analysis for Patient With Lung Cancer Using Computed Tomography Image Analysis
- ClinicalTrials.gov ID
- NCT01887769
- Acronym / sponsor ID
- BAT-SCAN / 20824
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Body composition analysis, Ct-Scan, Muscle mass, Cachexia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 27 Jun 2013 (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.
Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. However, despite the importance of cachexia in lung cancer, it has been mainly studied from several assessment methods which do not usually differentiate muscle from other tissues.
Aim: To analyze body composition of patients with lung cancer at diagnosis using computed tomography (CT-Scan) image analysis.
Methods: This is a retrospective study extending over a period of 3 years conducted at the Institut universitaire de cardiologie et de pneumologie de Québec (2009-2012). We listed patients newly diagnosed with lung cancer who had a thoraco-abdominal CT-scan performed in our institution. Following the collection of clinical data from patient records, we used SliceOmatic software to quantify muscle area, visceral fat area and subcutaneous fat area from a single abdominal cross-sectional image at the level of the third lumbar vertebra.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer patient at diagnosis | – | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients, at diagnosis, following in oncology clinic
Key inclusion criteria (4 listed)
- Men or women
- Between 40-80 years of age
- Primary lung cancer diagnosed between 2009 and 2012
- CT-Scan done at the time of the diagnosis
Key exclusion criteria (2 listed)
- Chemotherapy, radiotherapy or surgery at the time of the first Ct-Scan image
- History of other cancer (during the last five years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of muscle area (cm2/m2) at the level of the third lumbar vertebra
Time frame: at the time of the diagnosis of lung cancer and one year following it.
Change of fat area (cm2/m2) at the level of the third lumbar vertebra
Time frame: at the time of the diagnosis of lung cancer and one year following it.
1 secondary outcome
days of survival
Time frame: From the time of the diagnosis of lung cancer until one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
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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.
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Canada
Didier Saey, PhD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
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 de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec 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 4 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: status not confirmed, as of the sponsor's last update on 6 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of muscle area (cm2/m2) at the level of the third lumbar vertebra (time frame: at the time of the diagnosis of lung cancer and one year following it.). The study lists 2 primary outcomes in all. 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 6 Jan 2017.