The ISET (Isolation by Size of Epithelial Tumor Cells) and the CellSearch Methods in Malignant Pleural Mesothelioma
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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? |
- 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.
- 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 |
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| Contact: ILIE Marius, PhD | +33 4 92 03 85 52 | ilie.m@chu-nice.fr |
| 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 | |
| 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 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 Neoplasms, Mesothelial Parathyroid Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Pleural Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013