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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01776385
First received: March 23, 2012
Last updated: January 23, 2013
Last verified: November 2012
  Purpose

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 Intervention
Pleural Neoplasms
Mesothelioma
Pneumothorax
Parathyroid Neoplasms
Benign Tumor of the Thyroid
Tumor of the Thyroid
Other: Blood sampling
Other: Control Group

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Evaluation of presence / absence of CTC on the global survival [ Time Frame: from Baseline in Systolic Blood Pressure at 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: from Baseline in Systolic Blood Pressure at 6 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 45
Study Start Date: February 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776385

Contacts
Contact: ILIE Marius, PhD +33 4 92 03 85 52 ilie.m@chu-nice.fr

Locations
France
CHU de Nice - LPCE- Hôpital de Pasteur - 30 ave de la voie Romaine Recruiting
Nice, Alpes-Maritimes, France, 06001
Contact: ILIE Marius, PhD    +33492038552    ilie.m@chu-nice.fr   
Principal Investigator: ILIE Marius, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: ILIE Marius, PhD LPCE- Hôpital de Pasteur - CHU de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01776385     History of Changes
Other Study ID Numbers: 11-AOI-08
Study First Received: March 23, 2012
Last Updated: January 23, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:
[C08.785.640]
(C08.528.778)
[C19.642.713]
mesothelium

Additional relevant MeSH terms:
Neoplasms
Thyroid Neoplasms
Mesothelioma
Neoplasms, Mesothelial
Parathyroid Neoplasms
Pleural Neoplasms
Pneumothorax
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Parathyroid Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014