Circulating Tumor Cells in Lung Cancer (CIRCUBRONCH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Central Hospital, Nancy, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr Christelle CLEMENT-DUCHENE, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01658332
First received: June 16, 2012
Last updated: August 6, 2012
Last verified: August 2012
  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: 18 months.

Duration of the study: 30 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
Stage IIIB Non Small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    epidemiological,and clinical characteristics of patients with advanced lung cancer


Estimated Enrollment: 200
Study Start Date: June 2012
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Advanced stage NSCLC (stages IIIB, and IV)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658332

Contacts
Contact: Christelle Clement-Duchene, MD, Principal Investigator +33 3 83 15 33 80 c.clement-duchene@chu-nancy.fr

Locations
France
Christelle Clement-Duchene Recruiting
Nancy, France, 54511
Principal Investigator: Christelle Clement-Duchene, MD         
Sponsors and Collaborators
Central Hospital, Nancy, France
  More Information

No publications provided

Responsible Party: Dr Christelle CLEMENT-DUCHENE, MD, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01658332     History of Changes
Other Study ID Numbers: 2012-A00135-38
Study First Received: June 16, 2012
Last Updated: August 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on September 22, 2014