Nuclear Matrix and Cancer: Proteomic and Genomic Analyses Using Microarray in Cells Obtained Via Thoracocentesis

August 28, 2014 updated by: Assistance Publique Hopitaux De Marseille
Accurate characterization of malignant cells obtained via thoracocentesis is of paramount importance in the management of cancer patients. The identification of novel biomarkers may in that regard considerably improve the diagnostic approach of these pleural effusions, guide therapeutic decisions, particularly with respect to targeted therapies, and offer helpful prognostic information. Nuclear anomalies represent the cornerstone of the cytologic and/or histopathologic diagnosis of malignant cells. The nuclear matrix is a fundamental constituent of the nuclear architecture via its interaction with the nuclear membrane, but is also directly involved with DNA and RNA processing. Prior studies have suggested that in some cancers, the lamins, a major constituent of the nuclear matrix, have different patterns of expression or nuclear localization that could potentially have prognostic implications. Our project aims at studying the constituents of the nuclear matrix of malignant cells isolated for pleural fluid in patients with metastatic disease, both of bronchogenic or non-bronchogenic origin, which, to our knowledge, has not yet been done. Both proteomic (localization by immunofluorescence and expression by Western-Blot) and genomic (microarray, CGH type) analyses will be undertaken to identify microrearrangements in the genes of interest. The primary aim is to identify specific biomarkers to more accurately characterize malignant cells in metastatic pleural disease.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille
      • Marseille, France, 13005
        • Assistance Publique Des Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with metastatic disease

Description

Inclusion Criteria:

  • sign consent approval
  • patients with metastatic disease, both of bronchogenic or non-bronchogenic origin
  • 50% or more of malignant cells

Exclusion Criteria:

  • patients with tumoral treatment during thoracocentesis
  • 50% or less of malignant cells

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients
20ml of blood only one thoracocentesis (the same that one for diagnostic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
identify specific biomarkers to more accurately characterize malignant cells in metastatic pleural disease
Time Frame: 2 years

Research for quantitative or qualitative nuclear-matrix-proteins anomalies in secondary metastatic pleural disease and/or for anomalies in the genes coding for these proteins.

Protein analysis : immunofluorenscy, western blot. Genomic analysis : CGH arrays.

2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variations of nuclear matrix proteins expression or localization in malignant cells released in pleural liquid
Time Frame: 2 years
2 years
Comparison of nuclear matrix protein expression in metastatic cells
Time Frame: 2 years
by taking account of the origin and the histological nature of the primitive tumor
2 years
Identify genomic anomalies of the interest genes
Time Frame: 2 years
the tumoral cells genome versus the peripheral cells genome
2 years
Search existence of a correlation between the quantity of expressed proteins and the number of genes copies in the tumoral cells
Time Frame: 2 years
2 years
Compare their results with the data published on cell-lineages and on tissular samples
Time Frame: 2 years
Showing differences between tumor cells, cell-lineages and cells released in the liquid
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patrice Roll, Assistance Publique Des Hopitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

January 26, 2011

First Posted (Estimate)

January 27, 2011

Study Record Updates

Last Update Posted (Estimate)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010-A00295-34
  • 2010-01 (internal number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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