Clinical trial NCT01776385: The ISET (Isolation by Size of Epithelial Tumor Cells) and the CellSearch Methods in Malignant Pleural Mesothelioma
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Neoplasms
Mesothelioma
Pneumothorax
Parathyroid Neoplasms
Benign Tumor of the Thyroid
Tumor of the Thyroid
Keywords: [C08.785.640]
(C08.528.778)
[C19.642.713]
mesothelium
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Evaluation of presence / absence of CTC on the global survival
timeFrame: from Baseline in Systolic Blood Pressure at 6 months
Secondary outcomes:
measure: Value forecasts of the number of CTC on the global survival estimated by the risk
timeFrame: from Baseline in Systolic Blood Pressure at 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - LPCE- Hôpital de Pasteur - 30 ave de la voie Romaine
state: Alpes-Maritimes
Study officials:
affiliation: LPCE- Hôpital de Pasteur - CHU de Nice
name: ILIE Marius, PhD
role: PRINCIPAL_INVESTIGATOR
References: