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

NCT00818558 | Completed

• 1 other identifier: 04-APN-08
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

non small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Presence or absence of circulating tumoral Cells(Units) according to: 1) The pTNM stage 2) the histological type

  immediately

Secondary Outcomes (1)

• Specific survival and global survival, recurrence and metastasis

  in 2 years, 3 years and 5 years

Study Arms (6)

1

EXPERIMENTAL

stade IA \[pT1 N0M0\]

Biological: ISET Methode

2

EXPERIMENTAL

stade IB \[pT2 N0M0\]

Biological: ISET Methode

3

EXPERIMENTAL

stade IIA \[pTI N1M0\]

Biological: ISET Methode

4

EXPERIMENTAL

stade IIB \[pT2 N1 et T3N0M0\]

Biological: ISET Methode

5

EXPERIMENTAL

control groupe \[tabagic subject\]

Biological: ISET Methode

6

EXPERIMENTAL

Control group B \[intervention for a pulmonaire non tumoral pulmonary lesion\]

Biological: ISET Methode

Interventions

ISET Methode BIOLOGICAL

Sampling of blood - ISET Methode

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Pr Paul HOFMAN

Nice, France

Location

Related Publications (1)

• Ilie M, Szafer-Glusman E, Hofman V, Long-Mira E, Suttmann R, Darbonne W, Butori C, Lalvee S, Fayada J, Selva E, Yu W, Marquette CH, Shames DS, Punnoose E, Hofman P. Expression of MET in circulating tumor cells correlates with expression in tumor tissue from advanced-stage lung cancer patients. Oncotarget. 2017 Apr 18;8(16):26112-26121. doi: 10.18632/oncotarget.15345.

  PMID: 28212540 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paul Pr Hofman, PU-PH

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 7, 2009
• Study Start: November 3, 2008
• Primary Completion: May 7, 2012
• Study Completion: October 31, 2012
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

FR (1)