NCT00001898

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 1999

Longer than P75 for all trials

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
8.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2008

Completed
Last Updated

July 2, 2017

Status Verified

May 20, 2008

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

MelanomaBreast CancerGene ExpressionDNA Chip TechnologyExpressed Sequence Tags

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-0624, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030-4096, United States

Location

Helsinki University Central Hospital

Helsinki, Finland

Location

University of Iceland

Reykjavik, Iceland

Location

University of Lund

Lund, Sweden

Location

Related 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. doi: 10.1038/1670.

    PMID: 9731524BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsNeoplastic Syndromes, HereditaryMelanomaOvarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

June 29, 1999

Study Completion

May 20, 2008

Last Updated

July 2, 2017

Record last verified: 2008-05-20

Locations