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Circulating Tumor Cells in Lung Cancer (CIRCUBRONCH)

This study has been terminated.
(unavailability of the investigator due to an overloaded planning)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01658332
First Posted: August 7, 2012
Last Update Posted: July 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Central Hospital, Nancy, France
  Purpose

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.


Condition Intervention
Stage IIIB Non Small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Other: blood samples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Circulating Tumor Cells Identification in Advanced Stage Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • Identification of circulating tumor cells in locally advanced, and metastatic non-small cell lung cancer. [ Time Frame: 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:
  • Identification of a cellular profile according to clinical factors (sex,histology, …). [ Time Frame: 18 months ]
    epidemiological,and clinical characteristics of patients with advanced lung cancer


Enrollment: 59
Study Start Date: June 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: specific procedure
Circulating tumor cells will be search with the Veridex method at inclusion and after the third chimiotherapy
Other: blood samples
3 tubes (15 ml)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658332


Locations
France
Christelle Clement-Duchene
Nancy, France, 54511
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Christelle CLEMENT-DUCHENE, MD CHU NANCY
  More Information

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01658332     History of Changes
Other Study ID Numbers: 2012-A00135-38
First Submitted: June 16, 2012
First Posted: August 7, 2012
Last Update Posted: July 30, 2015
Last Verified: July 2015

Keywords provided by Central Hospital, Nancy, France:
lung cancer
circulating tumor cells
prospective
monocentrique trial

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplastic Cells, Circulating
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes