Circulating Tumor Cells in Lung Cancer
Conditions
Stage IIIB Non Small Cell Lung Cancer - Stage IV Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms - Neoplastic Cells, Circulating
Conditions: Keywords
lung cancer, circulating tumor cells, prospective, monocentrique trial
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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: 18 months.

Duration of the study: 30 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: 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.
Location
Christelle Clement-Duchene
Nancy, France
Status: Recruiting
Start Date
June 2012
Sponsors
Central Hospital, Nancy, France
Source
Central Hospital, Nancy, France
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page