- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00340847
Construction and Use of Lung Tumor Microarray for the Analysis of Gene Expression in Lung Cancer
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI), 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA
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.
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999901233
- 01-C-N233
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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