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

NCT ID: NCT01776385

Last Updated: 2018-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2018-03-31

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group patients

Patients with Malignant Pleural Mesothelioma (all stages)

Group Type EXPERIMENTAL

Blood sampling

Intervention Type OTHER

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

Control group

Patients with pneumothorax or of benign tumor of the thyroid

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type OTHER

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

Interventions

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Blood sampling

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

Intervention Type OTHER

Control Group

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ILIE Marius, PhD

Role: PRINCIPAL_INVESTIGATOR

LPCE- Hôpital de Pasteur - CHU de Nice

Locations

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CHU de Nice - LPCE- Hôpital de Pasteur - 30 ave de la voie Romaine

Nice, Alpes-Maritimes, France

Site Status

Countries

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France

Other Identifiers

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11-AOI-08

Identifier Type: -

Identifier Source: org_study_id

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