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

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ClinicalTrials.gov Identifier: NCT01776385
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : February 2012
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

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




Primary Outcome Measures :
  1. Evaluation of presence / absence of CTC on the global survival [ Time Frame: 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 :
  1. Value forecasts of the number of CTC on the global survival estimated by the risk [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776385


Locations
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France
CHU de Nice - LPCE- Hôpital de Pasteur - 30 ave de la voie Romaine
Nice, Alpes-Maritimes, France, 06001
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: ILIE Marius, PhD LPCE- Hôpital de Pasteur - CHU de Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01776385     History of Changes
Other Study ID Numbers: 11-AOI-08
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: February 2018
Keywords provided by Centre Hospitalier Universitaire de Nice:
[C08.785.640]
(C08.528.778)
[C19.642.713]
mesothelium
Additional relevant MeSH terms:
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Mesothelioma
Parathyroid Neoplasms
Pleural Neoplasms
Thyroid Neoplasms
Pneumothorax
Thyroid Diseases
Neoplasms
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Pleural Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Parathyroid Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms