search
Back to results

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

Primary Purpose

Pleural Neoplasms, Mesothelioma, Pneumothorax

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Control Group
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pleural Neoplasms focused on measuring [C08.785.640], (C08.528.778), [C19.642.713], mesothelium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group patients

Control group

Arm Description

Patients with Malignant Pleural Mesothelioma (all stages)

Patients with pneumothorax or of benign tumor of the thyroid

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2012
Last Updated
July 20, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
search

1. Study Identification

Unique Protocol Identification Number
NCT01776385
Brief Title
The ISET (Isolation by Size of Epithelial Tumor Cells) and the CellSearch Methods in Malignant Pleural Mesothelioma
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?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Neoplasms, Mesothelioma, Pneumothorax, Parathyroid Neoplasms, Benign Tumor of the Thyroid, Tumor of the Thyroid
Keywords
[C08.785.640], (C08.528.778), [C19.642.713], mesothelium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group patients
Arm Type
Experimental
Arm Description
Patients with Malignant Pleural Mesothelioma (all stages)
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients with pneumothorax or of benign tumor of the thyroid
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods
Primary Outcome Measure Information:
Title
Evaluation of presence / absence of CTC on the global survival
Description
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.
Time Frame
from Baseline in Systolic Blood Pressure at 6 months
Secondary Outcome Measure Information:
Title
Value forecasts of the number of CTC on the global survival estimated by the risk
Description
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
Time Frame
from Baseline in Systolic Blood Pressure at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ILIE Marius, PhD
Organizational Affiliation
LPCE- Hôpital de Pasteur - CHU de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice - LPCE- Hôpital de Pasteur - 30 ave de la voie Romaine
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06001
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs