Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
59 participants
INTERVENTIONAL
2012-06-30
2017-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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specific procedure
Circulating tumor cells will be search with the Veridex method at inclusion and after the third chimiotherapy
blood samples
3 tubes (15 ml)
Interventions
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blood samples
3 tubes (15 ml)
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years.
* Measurable or evaluable disease according to RECIST criteria.
* Ability to sign informed consent.
Exclusion Criteria
* Prior chemotherapy, radiation or surgery for lung cancer.
* Inability to comply with study and/or follow-up procedures.
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Principal Investigators
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Christelle CLEMENT-DUCHENE, MD
Role: PRINCIPAL_INVESTIGATOR
CHU NANCY
Locations
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Christelle Clement-Duchene
Nancy, , France
Countries
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Other Identifiers
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2012-A00135-38
Identifier Type: -
Identifier Source: org_study_id
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