Circulating Tumor Cells in Lung Cancer

Stage IV Non-small Cell Lung Cancer Clinical Trial

— CIRCUBRONCH  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01658332
• Other study ID #: 2012-A00135-38
• Status: Terminated
• Phase: N/A
• First received: June 16, 2012
• Last updated: July 29, 2015
• Start date: June 2012
• Est. completion date: December 2017

Study information

• Verified date: July 2015
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplastic Cells, Circulating
• Stage IIIB Non Small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Intervention

Other:
• blood samples
3 tubes (15 ml)

Locations

Country	Name	City	State
France	Christelle Clement-Duchene	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of circulating tumor cells in locally advanced, and metastatic non-small cell lung cancer.	Circulating tumor cells will be search with the Veridex method, and a value per 7.5 f blood will be recorded.	18 months	No
Secondary	Identification of a cellular profile according to clinical factors (sex,histology, …).	epidemiological,and clinical characteristics of patients with advanced lung cancer	18 months	No