Mesothelioma Clinical Trial
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?
NCT number | NCT01776385 |
Other study ID # | 11-AOI-08 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2012 |
Est. completion date | March 2018 |
Verified date | February 2018 |
Source | Centre Hospitalier Universitaire de Nice |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | March 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nice - LPCE- Hôpital de Pasteur - 30 ave de la voie Romaine | Nice | Alpes-Maritimes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01950572 -
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
|
||
Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Recruiting |
NCT06057935 -
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
|
Phase 2 | |
Terminated |
NCT02838745 -
Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for MPM
|
Phase 1 | |
Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 | |
Recruiting |
NCT01912547 -
Thromboelastography During Surgery for Malignant Pleural Mesothelioma
|
Phase 0 | |
Completed |
NCT01521325 -
A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
|
Phase 1 | |
Recruiting |
NCT02073500 -
Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
|
||
Recruiting |
NCT00996385 -
Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma
|
Phase 2 | |
Completed |
NCT02467426 -
Isolated Thoracic Perfusion (ITP-F) for MPM
|
Phase 2 | |
Completed |
NCT00407459 -
Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma
|
Phase 2 | |
Completed |
NCT00787410 -
An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
|
Phase 2 | |
Terminated |
NCT01907100 -
Nintedanib (BIBF 1120) in Mesothelioma
|
Phase 2/Phase 3 | |
Completed |
NCT04056026 -
A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma
|
Early Phase 1 | |
Completed |
NCT02903914 -
Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT03319537 -
Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma
|
Phase 1/Phase 2 | |
Terminated |
NCT03685591 -
PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors
|
Phase 1 |