NCT01887769

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

5.2 years

First QC Date

February 13, 2013

Last Update Submit

January 5, 2017

Conditions

Keywords

Lung cancerBody composition analysisCt-ScanMuscle massCachexia

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Secondary Outcomes (1)

  • days of survival

    From the time of the diagnosis of lung cancer until one year

Study Arms (1)

Lung cancer patient at diagnosis

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Lung cancer patients, at diagnosis, following in oncology clinic

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsCachexia

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesWeight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Didier Saey, PhD

    Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 13, 2013

First Posted

June 27, 2013

Study Start

May 1, 2012

Primary Completion

July 1, 2017

Study Completion

October 1, 2017

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations