The ISET (Isolation by Size of Epithelial Tumor Cells) and the CellSearch Methods in Malignant Pleural Mesothelioma
Conditions
Pleural Neoplasms - Mesothelioma - Pneumothorax - Parathyroid Neoplasms - Benign Tumor of the Thyroid - Tumor of the Thyroid
Conditions: official terms
Mesothelioma - Neoplasms - Parathyroid Neoplasms - Pleural Neoplasms - Pneumothorax - Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
C08.785.640, (C08.528.778), C19.642.713, mesothelium
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: Blood sampling Type: Other
Name: Control Group Type: Other
Overall Status
Recruiting
Summary
Malignant pleural mesothelioma (MPM) has a growing incidence and in spite of early diagnostic, their outcome remains dismal. The evolution of MPM is often local with rare distant metastases. 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 carcinomas. In exchange, the prognostic value of CTC in MPM has not yet been evaluated.

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. Thus, the aim of our study is to evaluate the presence and the prognostic value of CTC in MPM by a double approach. In our setting, cytopathological analysis of circulating non hematological cells (CNHC), of epithelial origin, isolated according to their size (ISET, Isolation by Size of Epithelial Tumor cells) along with immunomagnetic selection, identification and enumeration of circulating epithelial cells in peripheral blood (CellSearch method) is considered a promising approach.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria

For the patients:

- Age > 18 years

- Patient having been operated for a strong suspicion of a pleural malignant tumoral lesion corresponding to a primitive pleural mesothelioma

- Signed patient consent

For the control subjects:

- Age > 18 years

- unhurt of any malignant or mild tumoral pathology or patients that must benefit from a surgical procedure for a benign lesion in other organ than the pleura or a pulmonary non tumoral lesion

- Signed patient consent

Exclusion Criteria :

- Patient with histories of cancer or the other synchronous cancer

- Patient with additives treatments

- Patient according to treatments additives others than protocols codified (in particular, platinum navelbine or gemcitabine platinum) for stages II

- HIV, hepatitis B or C infections

- Pregnant women
Location
CHU de Nice - LPCE- Hôpital de Pasteur - 30 ave de la voie Romaine
Nice, Alpes-Maritimes, France
Status: Recruiting
Contact: ILIE Marius, PhD - +33492038552 - ilie.m@chu-nice.fr
Start Date
February 2012
Completion Date
March 2014
Sponsors
Centre Hospitalier Universitaire de Nice
Source
Centre Hospitalier Universitaire de Nice
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page