Stage IIIB Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Conditions
Keywords
lung cancer, circulating tumor cells, prospective, monocentrique trial
Brief summary
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.
Interventions
OTHERblood samples
3 tubes (15 ml)
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Advanced stage NSCLC (stages IIIB, and IV) with measurable or evaluable disease at diagnosis. * Age ≥ 18 years. * Measurable or evaluable disease according to RECIST criteria. * Ability to sign informed consent.
Exclusion criteria
* Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers. * Prior chemotherapy, radiation or surgery for lung cancer. * Inability to comply with study and/or follow-up procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of circulating tumor cells in locally advanced, and metastatic non-small cell lung cancer. | 18 months | Circulating tumor cells will be search with the Veridex method, and a value per 7.5 f blood will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of a cellular profile according to clinical factors (sex,histology, …). | 18 months | epidemiological,and clinical characteristics of patients with advanced lung cancer |
Countries
France
Outcome results
None listed