CancerNCT01284777
Nuclear Matrix and Cancer: Proteomic and Genomic Analyses Using Microarray in Cells Obtained Via Thoracocentesis
An observational study of Cancer, run by Assistance Publique Hopitaux De Marseille at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- blood sample, thoracocentesis
- How many people
- 27 participants
- Where
- 2 sitesFrance
- Study dates
- May 2010to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with metastatic disease
Who may be able to join
- sign consent approval
- patients with metastatic disease, both of bronchogenic or non-bronchogenic origin
- 50% or more of malignant cells
Who cannot join
- patients with tumoral treatment during thoracocentesis
- 50% or less of malignant cells
Trial locations and contacts
2 sites in 1 country.
France2 sites
Assistance Publique des Hôpitaux de Marseille
Marseille, 13005
Assistance Publique Hopitaux de Marseille
Marseille, 13354
About this study
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
- Being tested
- blood sample, thoracocentesis
- Keywords
- cancerology, genetic
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample, thoracocentesisGenetic
20ml of blood only one thoracocentesis (the same that one for diagnostic)
| Study group | Role | What they receive |
|---|---|---|
| patients | Not described Receives: Genetic: blood sample, thoracocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
Variations of nuclear matrix proteins expression or localization in malignant cells released in pleural liquid
Measured: 2 years
Comparison of nuclear matrix protein expression in metastatic cells
by taking account of the origin and the histological nature of the primitive tumor
Measured: 2 years
Identify genomic anomalies of the interest genes
the tumoral cells genome versus the peripheral cells genome
Measured: 2 years
Search existence of a correlation between the quantity of expressed proteins and the number of genes copies in the tumoral cells
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startMay 2010
- Primary completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice Roll, Principal investigator, Assistance Publique des Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284777
- Sponsor's protocol ID
- 2010-A00295-34
- Other IDs
- 2010-01
- Status last verified
- Aug 2014
- First submitted
- 18 May 2010
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuclear Matrix and Cancer: Proteomic and Genomic Analyses Using Microarray in Cells Obtained Via Thoracocentesis
- ClinicalTrials.gov ID
- NCT01284777
- Acronym / sponsor ID
- 2010-A00295-34
- Conditions
- Cancer
- Keywords
- cancerology, genetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2012 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Genetic: blood sample, thoracocentesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with metastatic disease
Key inclusion criteria (3 listed)
- sign consent approval
- patients with metastatic disease, both of bronchogenic or non-bronchogenic origin
- 50% or more of malignant cells
Key exclusion criteria (2 listed)
- patients with tumoral treatment during thoracocentesis
- 50% or less of malignant cells
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample, thoracocentesis20ml of blood only one thoracocentesis (the same that one for diagnostic) | Genetic | patients |
Primary outcome
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.
5 secondary outcomes
Variations of nuclear matrix proteins expression or localization in malignant cells released in pleural liquid
Time frame: 2 years
Comparison of nuclear matrix protein expression in metastatic cells
Time frame: 2 years
Identify genomic anomalies of the interest genes
Time frame: 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
Compare their results with the data published on cell-lineages and on tissular samples
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice Roll principal investigator
Assistance Publique des Hôpitaux de Marseille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Assistance Publique Hopitaux De Marseille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identify specific biomarkers to more accurately characterize malignant cells in metastatic pleural disease (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2014.