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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01284777
First received: May 18, 2010
Last updated: March 31, 2011
Last verified: March 2011
  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

Resource links provided by NLM:


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 ] [ 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.



Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284777

Contacts
Contact: Patrice Roll +33491388470 patrice.roll@ap-hm.fr

Locations
France
Assistance Publique des Hôpitaux de Marseille Recruiting
Marseille, France, 13005
Contact: Patrice Roll    +33491388470    patrice.roll@ap-hm.fr   
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: PATRICE ROLL         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Patrice Roll Assistance Publique des Hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille, direction de la recherche
ClinicalTrials.gov Identifier: NCT01284777     History of Changes
Other Study ID Numbers: 2010-A00295-34, 2010-01
Study First Received: May 18, 2010
Last Updated: March 31, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
cancerology
genetic

ClinicalTrials.gov processed this record on July 24, 2014