Nuclear Matrix and Cancer: Proteomic and Genomic Analyses Using Microarray in Cells Obtained Via Thoracocentesis
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 18, 2010 | ||||
| Last Updated Date | March 31, 2011 | ||||
| Start Date ICMJE | May 2010 | ||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01284777 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nuclear Matrix and Cancer: Proteomic and Genomic Analyses Using Microarray in Cells Obtained Via Thoracocentesis | ||||
| Official Title ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | patients with metastatic disease |
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| Condition ICMJE | Cancer | ||||
| Intervention ICMJE | Genetic: blood sample, thoracocentesis
20ml of blood only one thoracocentesis (the same that one for diagnostic) |
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| Study Group/Cohort (s) | patients
Intervention: Genetic: blood sample, thoracocentesis |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01284777 | ||||
| Other Study ID Numbers ICMJE | 2010-A00295-34, 2010-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Assistance Publique Hopitaux De Marseille, direction de la recherche | ||||
| Study Sponsor ICMJE | Assistance Publique Hopitaux De Marseille | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique Hopitaux De Marseille | ||||
| Verification Date | March 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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