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

NCT01284777 | Completed

• 2 other identifiers: 2010-A00295-342010-01
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer

Keywords

cancerology; genetic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

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

  2 years

• Comparison of nuclear matrix protein expression in metastatic cells

  2 years

• Identify genomic anomalies of the interest genes

  2 years

• Search existence of a correlation between the quantity of expressed proteins and the number of genes copies in the tumoral cells

  2 years

• Compare their results with the data published on cell-lineages and on tissular samples

  2 years

Study Arms (1)

patients

Genetic: blood sample, thoracocentesis

Interventions

blood sample, thoracocentesis GENETIC

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

patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with metastatic disease

You may qualify if:

• sign consent approval
• patients with metastatic disease, both of bronchogenic or non-bronchogenic origin
• % or more of malignant cells

You may not qualify if:

• patients with tumoral treatment during thoracocentesis
• % or less of malignant cells

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (2)

Assistance Publique des Hôpitaux de Marseille

Marseille, 13005, France

Location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection; Thoracentesis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Paracentesis; Therapeutics

Study Officials

• Patrice Roll

  Assistance Publique des Hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: January 27, 2011
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

FR (2)