We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01284777
First Posted: January 27, 2011
Last Update Posted: August 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
  Purpose
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.

Condition Intervention
Cancer Genetic: blood sample, thoracocentesis

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Variations of nuclear matrix proteins expression or localization in malignant cells released in pleural liquid [ Time Frame: 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

  • Identify genomic anomalies of the interest genes [ Time Frame: 2 years ]
    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 ]
  • 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


Enrollment: 27
Study Start Date: May 2010
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients Genetic: blood sample, thoracocentesis
20ml of blood only one thoracocentesis (the same that one for diagnostic)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with metastatic disease
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284777


Locations
France
Assistance Publique des Hôpitaux de Marseille
Marseille, France, 13005
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Patrice Roll Assistance Publique des Hôpitaux de Marseille
  More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01284777     History of Changes
Other Study ID Numbers: 2010-A00295-34
2010-01 ( Other Identifier: internal number )
First Submitted: May 18, 2010
First Posted: January 27, 2011
Last Update Posted: August 29, 2014
Last Verified: August 2014

Keywords provided by Assistance Publique Hopitaux De Marseille:
cancerology
genetic