The ISET (Isolation by Size of Epithelial Tumor Cells) and the CellSearch Methods in Malignant Pleural Mesothelioma

NCT01776385 | Completed

• 1 other identifier: 11-AOI-08
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Value forecasts of the number of CTC on the global survival estimated by the risk

  from Baseline in Systolic Blood Pressure at 6 months

Study Arms (2)

Group patients

EXPERIMENTAL

Patients with Malignant Pleural Mesothelioma (all stages)

Other: Blood sampling

Control group

PLACEBO COMPARATOR

Patients with pneumothorax or of benign tumor of the thyroid

Other: Control Group

Interventions

Blood sampling OTHER

Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods

Group patients

Control Group OTHER

Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - LPCE- Hôpital de Pasteur - 30 ave de la voie Romaine

Nice, Alpes-Maritimes, 06001, France

Location

MeSH Terms

Conditions

Pleural Neoplasms; Mesothelioma; Pneumothorax; Parathyroid Neoplasms; Thyroid Neoplasms

Interventions

Blood Specimen Collection; Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Diseases; Respiratory Tract Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods

Study Officials

• ILIE Marius, PhD

  LPCE- Hôpital de Pasteur - CHU de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: January 28, 2013
• Study Start: February 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: July 23, 2018

Record last verified: 2018-02

Locations

FR (1)