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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00340847
Other study ID # 999901233
Secondary ID 01-C-N233
Status Completed
Phase N/A
First received June 19, 2006
Last updated June 30, 2017
Start date August 9, 2001
Est. completion date May 19, 2010

Study information

Verified date May 19, 2010
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date May 19, 2010
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility - 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Cancer Institute (NCI), 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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