Circulating Tumor Cells in Lung Cancer

NCT ID: NCT01658332

Last Updated: 2015-07-30

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stage IIIB Non Small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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

Group Type EXPERIMENTAL

blood samples

Intervention Type OTHER

3 tubes (15 ml)

Interventions

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blood samples

3 tubes (15 ml)

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

Other Identifiers

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2012-A00135-38

Identifier Type: -

Identifier Source: org_study_id

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