Trial Information
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?
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Evaluation of presence / absence of CTC on the global survival
Outcome Description:
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.
Outcome Time Frame:
from Baseline in Systolic Blood Pressure at 6 months
Safety Issue:
No
Principal Investigator
ILIE Marius, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
LPCE- Hôpital de Pasteur - CHU de Nice
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
11-AOI-08
NCT ID:
NCT01776385
Start Date:
February 2012
Completion Date:
March 2014
Related Keywords:
- Pleural Neoplasms
- Mesothelioma
- Pneumothorax
- Parathyroid Neoplasms
- Benign Tumor of the Thyroid
- Tumor of the Thyroid
- [C08.785.640]
- (C08.528.778)
- [C19.642.713]
- mesothelium
- Neoplasms
- Thyroid Neoplasms
- Mesothelioma
- Parathyroid Neoplasms
- Pleural Neoplasms
- Pneumothorax
- Thyroid Diseases