Circulating Tumor Cells in Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Circulating Tumor Cells Identification in Advanced Stage Non-small Cell Lung Cancer

Conditions
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Stage IIIB Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Intervention / Treatment
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* Other: blood samples


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: specific procedure<br>Circulating tumor cells will be search with the Veridex method at inclusion and after the third chimiotherapy | Other: blood samples<br>* 3 tubes (15 ml)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of circulating tumor cells in locally advanced, and metastatic non-small cell lung cancer. | Circulating tumor cells will be search with the Veridex method, and a value per 7.5 f blood will be recorded. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of a cellular profile according to clinical factors (sex,histology, …). | epidemiological,and clinical characteristics of patients with advanced lung cancer | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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circulating tumor cells, monocentrique trial, lung cancer, prospective