Circulating Tumor Cells in Lung Cancer (CIRCUBRONCH)
Primary Purpose
Stage IIIB Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Stage IIIB Non Small Cell Lung Cancer focused on measuring lung cancer, circulating tumor cells, prospective, monocentrique trial
Eligibility Criteria
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.
Sites / Locations
- Christelle Clement-Duchene
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
specific procedure
Arm Description
Circulating tumor cells will be search with the Veridex method at inclusion and after the third chimiotherapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Identification of a cellular profile according to clinical factors (sex,histology, …).
epidemiological,and clinical characteristics of patients with advanced lung cancer
Full Information
NCT ID
NCT01658332
First Posted
June 16, 2012
Last Updated
July 29, 2015
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT01658332
Brief Title
Circulating Tumor Cells in Lung Cancer
Acronym
CIRCUBRONCH
Official Title
Circulating Tumor Cells Identification in Advanced Stage Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
unavailability of the investigator due to an overloaded planning
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IIIB Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Keywords
lung cancer, circulating tumor cells, prospective, monocentrique trial
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
specific procedure
Arm Type
Experimental
Arm Description
Circulating tumor cells will be search with the Veridex method at inclusion and after the third chimiotherapy
Intervention Type
Other
Intervention Name(s)
blood samples
Intervention Description
3 tubes (15 ml)
Primary Outcome Measure Information:
Title
Identification of circulating tumor cells in locally advanced, and metastatic non-small cell lung cancer.
Description
Circulating tumor cells will be search with the Veridex method, and a value per 7.5 f blood will be recorded.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Identification of a cellular profile according to clinical factors (sex,histology, …).
Description
epidemiological,and clinical characteristics of patients with advanced lung cancer
Time Frame
18 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christelle CLEMENT-DUCHENE, MD
Organizational Affiliation
CHU NANCY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christelle Clement-Duchene
City
Nancy
ZIP/Postal Code
54511
Country
France
12. IPD Sharing Statement
Learn more about this trial
Circulating Tumor Cells in Lung Cancer
We'll reach out to this number within 24 hrs