Circulating Tumor Cells in Lung Cancer (CIRCUBRONCH)

Central Hospital, Nancy, France

Status: Terminated

Conditions: Stage IIIB Non Small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Treatments: Other: blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT01658332

2012-A00135-38

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

59 participants in 1 patient group

specific procedure

Experimental group

Description:

Circulating tumor cells will be search with the Veridex method at inclusion and after the third chimiotherapy

Treatment:

Other: blood samples