Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
Circulating Tumor Cells Identification in Advanced Stage Non-small Cell Lung Cancer
TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer
(CIRCUBRONCH)
BACKGROUND : Circulating tumor cells identification is a new field of research in oncology,
and some studies have been conducted with success on breast and prostate cancer. Nearly 80%
of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells
identification and monitoring these cells after treatment could help the clinicians to
detect relapse or be a prognostic factor.
PRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage
lung cancers (IIIB and IV).
SECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the
therapeutic response. Prognostic value of identification of circulating tumor cells at the
time of diagnosis.
STUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification
of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers.
Duration of the inclusions: 54 months.
Duration of the study: 66 months.
PROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a
cut-off of 5 cells/7,5 ml of blood.
SAMPLE SIZE : 200 patients
STATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage
IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5
circulating tumor cells per 7,5 ml of blood.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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