Microarray Analysis for Human Genetic Disease

Melanoma Clinical Trial

Official title:

Microarray Analysis for Human Genetic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001898
• Other study ID #: 990130
• Secondary ID: 99-HG-0130
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: June 30, 2017
• Start date: June 29, 1999
• Est. completion date: May 20, 2008

Study information

• Verified date: May 20, 2008
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will look at genetic changes which occur in the development of male and female breast cancer and other cancer. It will use a new technology called DNA microarray hybridization that looks at a wide array of genes to identify disease-associated patterns in the human genome (complete set of human genes). Numerous studies have linked particular genes to a given disease, but there is very little information on patterns of gene expression (production of proteins from genetic coding) in the entire human genome.

Pinpointing genetic abnormalities in disease may help classify different forms of cancer and perhaps lead to new avenues of treatment or prevention. A primary goal of this study will be to create a database of gene expression for human cancers and other disorders that will provide the basis for finding genetic abnormalities in disease.

Tumors specimens used in this study will be taken from tissues biopsied from patients with breast, colon cancer, sarcomas or melanoma as part of their routine care. Patients in the study will be among those receiving care at the: Department of Oncology, University Hospital, University of Lund, Sweden (breast cancer); Department of Medicine, University of Michigan, Ann Arbor, Michigan (breast cancer); Surgery Branch, National Cancer Institute, Bethesda, Maryland (melanoma), Johns Hopkins Univ. (colon cancer), Memorial Sloan Kettering (sarcoma).

Patients in the study will have a family history taken and will complete a questionnaire. Some patients will be asked to have a blood test. Breast cancer patients will have a mammogram if one has not been done within the last year.

Description:

The purpose of our study is to make use of a novel technology that the Cancer Genetics Branch of the NHGRI has been a leader in developing. This technology for genome-wide expression analysis, DNA microarray hybridization, is the focus of our protocol. We will access tissue banks collected by our collaborators that contain excess tissues obtained during routine clinical care. Specimens will be processed for large-scale gene expression analysis and DNA copy number determination using DNA microarrays. The development and analysis of this gene expression and gene copy number database are the primary purpose of this study. Currently available and new bioinformatics tools will be applied to the data for the characterization of disease subsets (e.g., early vs. advanced stage cancer) as well as to mine the data for specific genes which are linked to given disease states.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: May 20, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

• Clinical inclusion/exclusion criteria will be dependent upon the collaborating Institutions' requirements.

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Hereditary Neoplastic Syndrome
• Melanoma
• Neoplasms
• Neoplastic Syndromes, Hereditary
• Ovarian Neoplasm
• Ovarian Neoplasms

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Iceland	University of Iceland	Reykjavik
Sweden	University of Lund	Lund
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	MD Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
National Human Genome Research Institute (NHGRI)

Countries where clinical trial is conducted

United States,  Finland,  Iceland,  Sweden, 

References & Publications (1)

Ermolaeva O, Rastogi M, Pruitt KD, Schuler GD, Bittner ML, Chen Y, Simon R, Meltzer P, Trent JM, Boguski MS. Data management and analysis for gene expression arrays. Nat Genet. 1998 Sep;20(1):19-23. — View Citation