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

Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284777
• Other study ID #: 2010-A00295-34
• Secondary ID: 2010-01
• Status: Completed
• Phase: N/A
• First received: May 18, 2010
• Last updated: August 28, 2014
• Start date: May 2010

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Intervention

Genetic:
• blood sample, thoracocentesis
20ml of blood only one thoracocentesis (the same that one for diagnostic)

Locations

Country	Name	City	State
France	Assistance Publique des Hôpitaux de Marseille	Marseille
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	identify specific biomarkers to more accurately characterize malignant cells in metastatic pleural disease	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	No
Secondary	Variations of nuclear matrix proteins expression or localization in malignant cells released in pleural liquid		2 years	No
Secondary	Comparison of nuclear matrix protein expression in metastatic cells	by taking account of the origin and the histological nature of the primitive tumor	2 years	No
Secondary	Identify genomic anomalies of the interest genes	the tumoral cells genome versus the peripheral cells genome	2 years	No
Secondary	Search existence of a correlation between the quantity of expressed proteins and the number of genes copies in the tumoral cells		2 years	No
Secondary	Compare their results with the data published on cell-lineages and on tissular samples	Showing differences between tumor cells, cell-lineages and cells released in the liquid	2 years	No