Clinical trial NCT01284777: Nuclear Matrix and Cancer: Proteomic and Genomic Analyses Using Microarray in Cells Obtained Via Thoracocentesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: cancerology
genetic
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with metastatic disease

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.


Eligibility 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

Primary outcomes:
measure: identify specific biomarkers to more accurately characterize malignant cells in metastatic pleural disease
timeFrame: 2 years
Secondary outcomes:
measure: Variations of nuclear matrix proteins expression or localization in malignant cells released in pleural liquid
timeFrame: 2 years
measure: Comparison of nuclear matrix protein expression in metastatic cells
timeFrame: 2 years
measure: Identify genomic anomalies of the interest genes
timeFrame: 2 years
measure: Search existence of a correlation between the quantity of expressed proteins and the number of genes copies in the tumoral cells
timeFrame: 2 years
measure: Compare their results with the data published on cell-lineages and on tissular samples
timeFrame: 2 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique des Hôpitaux de Marseille
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique des Hôpitaux de Marseille
name: Patrice Roll
role: PRINCIPAL_INVESTIGATOR
References: