Circulating Tumor Cells in Lung Cancer

Not Applicable

Terminated

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

• Registration Number: NCT01658332
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-16
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-07
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-30
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Christelle Clement-Duchene; 🇫🇷 Nancy, France