Benign Tumor of the Thyroid, Mesothelioma, Parathyroid Neoplasms, Pleural Neoplasms, Pneumothorax, Tumor of the Thyroid
Conditions
Keywords
[C08.785.640], (C08.528.778), [C19.642.713], mesothelium
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.
Interventions
OTHERBlood sampling
Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods
OTHERControl Group
Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of presence / absence of CTC on the global survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Value forecasts of the number of CTC on the global survival estimated by the risk | 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 |
Countries
France
Outcome results
None listed