Circulating Tumor Cells in Lung Cancer

NCT01658332 | Terminated

• 1 other identifier: 2012-A00135-38
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lung cancer; circulating tumor cells; prospective; monocentrique trial

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Secondary Outcomes (1)

• Identification of a cellular profile according to clinical factors (sex,histology, …).

  18 months

Study Arms (1)

specific procedure

EXPERIMENTAL

Circulating tumor cells will be search with the Veridex method at inclusion and after the third chimiotherapy

Other: blood samples

Interventions

blood samples OTHER

3 tubes (15 ml)

specific procedure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Christelle Clement-Duchene

Nancy, 54511, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christelle CLEMENT-DUCHENE, MD

  CHU NANCY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2012
• First Posted: August 7, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

FR (1)