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The Method ISET (Insulation by Size of Epithelial Tumor Cells)

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ClinicalTrials.gov Identifier: NCT00818558
Recruitment Status : Unknown
Verified December 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : January 7, 2009
Last Update Posted : December 8, 2011
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:
The aim of this study is, i) to assess the presence and the frequency of CTC in NSCLC patients undergoing surgery by using cytopathological analysis after their isolation by size (ISET method), and, ii) to correlate the presence of CNHC with pTNM stage, histological subtype, and percentage of tumor cells present into the primary tumors.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Biological: ISET Methode Not Applicable

Detailed Description:
Lung cancer is the most prevalent neoplasm and the major cause of tumor-related mortality worldwide. Despite recent advances in the management of resected lung cancers (i.e., the use of adjuvant therapy) and more effective treatments of metastatic tumors (i.e., molecular targeted agents), the cure rate of patients with lung cancer remains low (. Histological classification of lung tumors distinguishes small (SCLC) and non-small cell lung cancers (NSCLC). Most NSCLC display three histological subtypes: adenocarcinoma, squamous cell carcinoma and large cell carcinoma. The prognosis of these three NSCLC subtypes is quite similar. In this regard, development and validation of new prognostic/predictive biomarkers from tumor tissues and biological fluids is one of the more promising domain in translational cancer research. However, the clinical impact of new biomarkers has to be carefully validated, including for NSCLC. While pTNM staging is currently the only validated prognostic factor used in NSCLC patients follow up and treatment, 25% to 50% of patients with early-stage I NSCLC show tumor recurrence following extensive tumor resection, indicating the urgent need of more sensitive prognostic markers. Furthermore, it has been reported that the presence of occult metastatic disease correlates with disease recurrence in stage I NSCLC patients. There is now a sizable body of evidence that metastases could develop from circulating tumor cells (CTC) spread in blood before or during surgery . Thus, sensitive and specific detection of CTC in blood is considered as a potentially relevant predictive biomarker for patients with NSCLC. Indeed, the main goal for preoperative detection of CTC is to identify patients with high risk of recurrence after surgery, in order to perform more adapted therapeutic strategy. Despite several studies reported about CTC detection, methodological aspects concerning sensitivity, specificity and reproducibility have prevented a clear appraisal of their clinical impact. While RT-PCR and immune-mediated methods can be very sensitive, specificity remains a critical issue for these approaches as no transcript or antigen is known at present specifically recognizing tumor cells from solid tumors . In this setting, cytopathological analysis of circulating non hematological cells (CNHC), of epithelial (CEC) and endothelial (CEN-C) origin, isolated according to their size (ISET, Isolation by Size of Epithelial Tumor cells) is considered a promising approach, as CNHC enrichment is very sensitive and cell morphology is not damaged allowing to apply classical cytopathological criteria to identify tumor cells. In this regard, ISET technology has been previously reported to allow identification of CTC in patients with liver and breast tumors. However, ISET method has never been used to detect CTC in patients with NSCLC. The aim of this study is to determine the diagnostic potential of ISET method for preoperative detection of CTC in NSCLC patients. For this purpose cytomorphological criteria have been established by a group of 10 cytologists to classify CNHC in 3 groups : i) CNHC with malignant features (CNHC-MF) , ii) CNHC with uncertain features (CNHC-UMF), and, iii) CNHC with benign features (CNHC-BF). The presence and number of these circulating cells are then correlated with pTNM, histological subtype, and percentage of tumor cells into the primary tumors.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Value Forecasts of the Identification of the Circulating Tumoral Cells (CTC) in the Broncho-lung Carcinomas Not in Small Cells of Stages I and II by the Method ISET (Insulation by Size of Epithelial Tumor Cells)
Study Start Date : October 2008
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 1
stade IA [pT1 N0M0]
Biological: ISET Methode
Sampling of blood - ISET Methode

Experimental: 2
stade IB [pT2 N0M0]
Biological: ISET Methode
Sampling of blood - ISET Methode

Experimental: 3
stade IIA [pTI N1M0]
Biological: ISET Methode
Sampling of blood - ISET Methode

Experimental: 4
stade IIB [pT2 N1 et T3N0M0]
Biological: ISET Methode
Sampling of blood - ISET Methode

Experimental: 5
control groupe [tabagic subject]
Biological: ISET Methode
Sampling of blood - ISET Methode

Experimental: 6
Control group B [intervention for a pulmonaire non tumoral pulmonary lesion]
Biological: ISET Methode
Sampling of blood - ISET Methode




Primary Outcome Measures :
  1. Presence or absence of circulating tumoral Cells(Units) according to: 1) The pTNM stage 2) the histological type [ Time Frame: immediately ]

Secondary Outcome Measures :
  1. Specific survival and global survival, recurrence and metastasis [ Time Frame: in 2 years, 3 years and 5 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For the patients:

  • patient having been operated for a strong suspicion or a suspicion of a malignant tumoral hurt corresponding to a primitive carcinoma not in small cell of the lung

For the control subjects:

  • Tabagical patients (between 10 and 30 packages years)
  • unhurt of any malignant or mild tumoral pathology or patients that must benefit from a surgical operation for an extract of a hurt lung parenchymateuse for a not tumoral hurt

Exclusion Criteria:

  • Patient with histories of cancer or the other synchronous cancer
  • Patient with carcinomas with small cells, bronchiolo-alveolar carcinomas, the other types of tumors (lymphomes, sarcomas, etc.).
  • Patient with neoadditives treatments
  • Patient according to treatments additives others than protocols codified (in particular, platinum navelbine or gemcitabine platinum) for stages II

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): NCT00818558


Contacts
Contact: Paul Pr HOFMAN, PU-PH 04 92 03 87 49 hofman.p@chu-nice.fr

Locations
France
Pr Paul HOFMAN Recruiting
Nice, France
Contact: Paul Pr Hofman, PU-PH    04 92 03 87 49    hofman.p@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Paul Pr Hofman, PU-PH CHU de Nice

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00818558     History of Changes
Other Study ID Numbers: 04-APN-08
First Posted: January 7, 2009    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011

Keywords provided by Centre Hospitalier Universitaire de Nice:
non small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases