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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Completed

CT.gov ID

NCT01776385

Collaborator

(none)

Enrollment

Location

Arms

72.9

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pleural Neoplasms Mesothelioma Pneumothorax Parathyroid Neoplasms Benign Tumor of the Thyroid Tumor of the Thyroid	Other: Blood sampling Other: Control Group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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?

Actual Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Group patients

Patients with Malignant Pleural Mesothelioma (all stages)

Other: Blood sampling

Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods

Placebo Comparator: Control group

Patients with pneumothorax or of benign tumor of the thyroid

Other: Control Group

Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods

Outcome Measures

Primary Outcome Measures

Evaluation of presence / absence of CTC on the global survival [from Baseline in Systolic Blood Pressure at 6 months]
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.

Secondary Outcome Measures

Value forecasts of the number of CTC on the global survival estimated by the risk [from Baseline in Systolic Blood Pressure at 6 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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