Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group patients | Experimental | Patients with Malignant Pleural Mesothelioma (all stages) |
|
| Control group | Placebo Comparator | Patients with pneumothorax or of benign tumor of the thyroid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Other | Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from Baseline in Systolic Blood Pressure at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from Baseline in Systolic Blood Pressure at 6 months |
Not provided
Inclusion Criteria
For the patients:
For the control subjects:
Exclusion Criteria :
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ILIE Marius, PhD | LPCE- Hôpital de Pasteur - CHU de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice - LPCE- Hôpital de Pasteur - 30 ave de la voie Romaine | Nice | Alpes-Maritimes | 06001 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control Group | Other | Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods |
|
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D008654 | Mesothelioma |
| D011030 | Pneumothorax |
| D010282 | Parathyroid Neoplasms |
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D004701 | Endocrine Gland Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D010279 | Parathyroid Diseases |
| D013959 | Thyroid Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D012107 | Research Design |
| D008722 | Methods |
Not provided
Not provided