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OpenTrials
Completed

NCT Number: NCT01284777

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hopitaux de Marseille, Marseille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample, thoracocentesis

Genetic

20ml of blood only one thoracocentesis (the same that one for diagnostic)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Variations of nuclear matrix proteins expression or localization in malignant cells released in pleural liquid

    Time frame: 2 years

  2. 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

  3. Identify genomic anomalies of the interest genes

    Time frame: 2 years

    the tumoral cells genome versus the peripheral cells genome

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
First posted
Jan 27, 2011
Registry last updated
Aug 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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