The ISET (Isolation by Size of Epithelial Tumor Cells) and the CellSearch Methods in Malignant Pleural Mesothelioma

Study Overview
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Brief Summary
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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.

Official Title
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Detection and Characterization of Circulating Tumor Cells in Patients With Malignant Pleural Mesothelioma: Towards a New Phase in the Understanding of the Natural History of This Cancer?

Conditions
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Pleural Neoplasms, Mesothelioma, Pneumothorax, Parathyroid Neoplasms, Benign Tumor of the Thyroid, Tumor of the Thyroid

Intervention / Treatment
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* Other: Blood sampling
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group patients<br>Patients with Malignant Pleural Mesothelioma (all stages) | Other: Blood sampling<br>* Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods<br>|
| Placebo Comparator: Control group<br>Patients with pneumothorax or of benign tumor of the thyroid | Other: Control Group<br>* Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of presence / absence of CTC on the global survival | Value forecasts of the presence / absence of CTC on the global survival estimated by the estimation and the test of meaning at 0 of the immediate relative risk (fate ratio) in a model at proportional risk. | from Baseline in Systolic Blood Pressure at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value forecasts of the number of CTC on the global survival estimated by the risk | Value forecasts of the number of CTC on the global survival estimated by the immediate relative risk Value forecasts of the presence / absence and the number of CTC on the survival without second offense(recurrence) or metastasis estimated by the immediate relative risk | from Baseline in Systolic Blood Pressure at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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[C08.785.640], (C08.528.778), [C19.642.713], mesothelium