- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01284777
Nuclear Matrix and Cancer: Proteomic and Genomic Analyses Using Microarray in Cells Obtained Via Thoracocentesis
August 28, 2014 updated by: Assistance Publique Hopitaux De Marseille
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
27
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
-
Marseille, France, 13005
- Assistance Publique Des Hopitaux de Marseille
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with metastatic disease
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients
|
20ml of blood only one thoracocentesis (the same that one for diagnostic)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
identify specific biomarkers to more accurately characterize malignant cells in metastatic pleural disease
Time Frame: 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Variations of nuclear matrix proteins expression or localization in malignant cells released in pleural liquid
Time Frame: 2 years
|
2 years
|
|
|
Comparison of nuclear matrix protein expression in metastatic cells
Time Frame: 2 years
|
by taking account of the origin and the histological nature of the primitive tumor
|
2 years
|
|
Identify genomic anomalies of the interest genes
Time Frame: 2 years
|
the tumoral cells genome versus the peripheral cells genome
|
2 years
|
|
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
|
2 years
|
|
|
Compare their results with the data published on cell-lineages and on tissular samples
Time Frame: 2 years
|
Showing differences between tumor cells, cell-lineages and cells released in the liquid
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Patrice Roll, Assistance Publique Des Hopitaux de Marseille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
May 18, 2010
First Submitted That Met QC Criteria
January 26, 2011
First Posted (Estimate)
January 27, 2011
Study Record Updates
Last Update Posted (Estimate)
August 29, 2014
Last Update Submitted That Met QC Criteria
August 28, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2010-A00295-34
- 2010-01 (internal number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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