Circulating Tumor Cells in Lung Cancer (CIRCUBRONCH)
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|ClinicalTrials.gov Identifier: NCT01658332|
Recruitment Status : Terminated (unavailability of the investigator due to an overloaded planning)
First Posted : August 7, 2012
Last Update Posted : July 30, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Stage IIIB Non Small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer||Other: blood samples||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Circulating Tumor Cells Identification in Advanced Stage Non-small Cell Lung Cancer|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658332
|Nancy, France, 54511|
|Principal Investigator:||Christelle CLEMENT-DUCHENE, MD||CHU NANCY|