Circulating Tumor Cells in Lung Cancer

Not Applicable

Terminated

• Conditions: Stage IIIB Non Small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
• Interventions: Other: blood samples

• 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

Arm && Interventions

Group	Intervention	Description
specific procedure	blood samples	Circulating tumor cells will be search with the Veridex method at inclusion and after the third chimiotherapy

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