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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01284777
First received: May 18, 2010
Last updated: August 28, 2014
Last verified: August 2014

May 18, 2010
August 28, 2014
May 2010
May 2012   (final data collection date for primary outcome measure)
identify specific biomarkers to more accurately characterize malignant cells in metastatic pleural disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01284777 on ClinicalTrials.gov Archive Site
  • Variations of nuclear matrix proteins expression or localization in malignant cells released in pleural liquid [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Comparison of nuclear matrix protein expression in metastatic cells [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    by taking account of the origin and the histological nature of the primitive tumor
  • Identify genomic anomalies of the interest genes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    the tumoral cells genome versus the peripheral cells genome
  • 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 ] [ Designated as safety issue: No ]
  • Compare their results with the data published on cell-lineages and on tissular samples [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Showing differences between tumor cells, cell-lineages and cells released in the liquid
Same as current
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Nuclear Matrix and Cancer: Proteomic and Genomic Analyses Using Microarray in Cells Obtained Via Thoracocentesis
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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.

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Observational
Time Perspective: Prospective
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Probability Sample

patients with metastatic disease

Cancer
Genetic: blood sample, thoracocentesis
20ml of blood only one thoracocentesis (the same that one for diagnostic)
patients
Intervention: Genetic: blood sample, thoracocentesis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
Not Provided
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01284777
2010-A00295-34, 2010-01
No
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: Patrice Roll Assistance Publique des Hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP