Circulating Tumor Cells in Lung Cancer (CIRCUBRONCH)
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.
Stage IIIB Non Small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Other: blood samples
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Circulating Tumor Cells Identification in Advanced Stage Non-small Cell Lung Cancer|
- Identification of circulating tumor cells in locally advanced, and metastatic non-small cell lung cancer. [ Time Frame: 18 months ]Circulating tumor cells will be search with the Veridex method, and a value per 7.5 f blood will be recorded.
- Identification of a cellular profile according to clinical factors (sex,histology, …). [ Time Frame: 18 months ]epidemiological,and clinical characteristics of patients with advanced lung cancer
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: specific procedure
Circulating tumor cells will be search with the Veridex method at inclusion and after the third chimiotherapy
Other: blood samples
3 tubes (15 ml)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658332
|Nancy, France, 54511|
|Principal Investigator:||Christelle CLEMENT-DUCHENE, MD||CHU NANCY|