Clinical trial NCT01887769: Body Composition Analysis for Patient With Lung Cancer Using Computed Tomography Image Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Lung cancer
Body composition analysis
Ct-Scan
Muscle mass
Cachexia
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lung cancer patients, at diagnosis, following in oncology clinic

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Chemotherapy, radiotherapy or surgery at the time of the first Ct-Scan image
* History of other cancer (during the last five years)

Primary outcomes:
measure: Change of muscle area (cm2/m2) at the level of the third lumbar vertebra
timeFrame: at the time of the diagnosis of lung cancer and one year following it.
measure: Change of fat area (cm2/m2) at the level of the third lumbar vertebra
timeFrame: at the time of the diagnosis of lung cancer and one year following it.
Secondary outcomes:
measure: days of survival
timeFrame: From the time of the diagnosis of lung cancer until one year
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Didier Saey, PhD
role: PRINCIPAL_INVESTIGATOR
References: