Construction and Use of Lung Tumor Microarray for the Analysis of Gene Expression in Lung Cancer
|First Received Date ICMJE||June 19, 2006|
|Last Updated Date||May 20, 2010|
|Start Date ICMJE||August 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00340847 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Construction and Use of Lung Tumor Microarray for the Analysis of Gene Expression in Lung Cancer|
|Official Title ICMJE||Construction and Use of Lung Tumor Microarray for the Analysis of Gene Expression in Lung Cancer|
The proposed research intends to construct a set of tissue microarrays containing different types of normal and lung cancer tissues for the study of genes associated with lung cancer. Thus far we have generated a lung cancer tissue arrayusing paraffin embedded archival tissues from 300 lung turmors tissues and 100 adjacent normal tissues. Four- micrometer thickness sections have been cut from the tissue array and were used to survey gene expression status in arrayed tumors using immunohistochemistry methody. We are currently performing IHC studies ot 1) determine protein expression and its correlation with gene expression patterms ovserved using cDNA arrays. 2) Analyze protein expression in the chromosome remodeling pathyway in non-small cell lung cancer. And 3) determine the association of gene expression with lung tumor stage and clinical outcome. The current protocol is needed to complete the above studies and for the production of neuroendocrine tumors.
The proposed research intends to construct a set of tissue microarrays containing different types of lung cancer tissues for the study of genes associated with lung cancer. In this study, lung tissue arrays will be generated using paraffin embedded archival tissues containing adjacent normal tissues and tumors from approximately 300 non-small cell lung cancers and 100 neuroendocrine tumors of the lung. Corded tissues of 0.6 um in diameter will be taken from each tumor and arrayed onto recipient paraffin blocks to generate a lung tumor specific microarray. Four-micrometer thickness sections will be cut from the tissue array and used to survey gene expression status in arrayed tumors using fluorescence in situ hybridization (FISH, in situ hybridization, and/or immunohistochemistry methods. Additionally, approximately 20 sections will be cut from each primary tumor block to isolate genomic DNA for the analysis of genetic changes in the arrayed tumor samples. The goals of this proposal are 1) to generate a single tissue block containing multiple tumors, 2) allow rapid and efficient analysis of gene expressions in a large number of samples using a single tissue section, and 3) to correlate the molecular changes in the tumors with the clinical and pathological features of the disease. Due to the experimental nature of the research and the fact that all tumors obtained are archival tissues at AFIP, the investigators will not report the result of gene expression back to the subject.
To date, all samples needed for the protocol have been reached and there will be no more patient accrual but survival status of the patients as well as molecular analysis using the constructed lung tissue microarrays will continue for the foreseeable future.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Lung Cancer|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||500|
|Completion Date||May 2010|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
The human tissue microarrays will include existing archival tissues of normal lung, non small-cell lung cancer, and combined histological types of lung cancer samples. All tissue samples are already in existence at the Armed Forces Institute of Pathology.
The primary selection criteria will be the type of cancer, the quality of the tumor block, and the availability of the sample without regard to age, race, ethnic origin, and gender of the patient.
Only tissue blocks of suitable fixation quality and proper diagnosis will be used to generate the lung tissue microarrays.
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00340847|
|Other Study ID Numbers ICMJE||999901233, 01-C-N233|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP