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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01887769
Other study ID # 20824
Secondary ID
Status Recruiting
Phase N/A
First received February 13, 2013
Last updated January 5, 2017
Start date May 2012
Est. completion date October 2017

Study information

Verified date January 2017
Source Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date October 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Institut universitaire de cardiologie et de pneumologie de Québec Québec Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of muscle area (cm2/m2) at the level of the third lumbar vertebra at the time of the diagnosis of lung cancer and one year following it. No
Primary Change of fat area (cm2/m2) at the level of the third lumbar vertebra at the time of the diagnosis of lung cancer and one year following it. No
Secondary days of survival From the time of the diagnosis of lung cancer until one year No
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