CIRCUBRONCH: Circulating Tumor Cells in Lung Cancer

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Terminated

CT.gov ID

NCT01658332

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stage IIIB Non Small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer	Other: blood samples	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Identification of a cellular profile according to clinical factors (sex,histology, …). [18 months]
epidemiological,and clinical characteristics of patients with advanced lung cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.