Genes That Affect Disease Progression in Women With Newly Diagnosed or Metastatic Breast Cancer - Full Text View

Sponsored by:	University of Sheffield
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00463034

Purpose

RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment.

PURPOSE: This clinical trial is assessing how changes in genes affect disease progression in women with newly diagnosed or metastatic breast cancer.

Condition	Intervention
Breast Cancer	Procedure: gene expression profiling Procedure: high performance liquid chromatography Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: polymerase chain reaction Procedure: polymorphism analysis Procedure: questionnaire administration

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	Genetic Factors Affecting Breast Cancer Progression

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Correlation of inherited and acquired variations in candidate genes with breast cancer progression and survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Establishment of a repository of blood and tumor samples [ Designated as safety issue: No ]

Estimated Enrollment:	1800
Study Start Date:	April 2005
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Correlate inherited and acquired variations in candidate genes with breast cancer progression and survival in women with newly diagnosed or metastatic breast cancer.

Secondary

Establish a repository of blood and tumor samples from these patients, linked to a database of clinical, pathological, and treatment outcome data for future research studies.

OUTLINE: Patients complete epidemiological questionnaires and undergo blood sample collection. Tumor tissue specimens are requested from the pathology departments.

Blood samples are analyzed for single nucleotide polymorphisms and other polymorphic variants in candidate genes by polymerase chain reaction. Candidate genes include genes involved in the DNA damage response, programed cell death, inflammation, and angiogenesis. Tumor samples are analyzed by tissue microarrays using immunohistochemistry, denaturing high-performance liquid chromatography, and DNA sequencing to study genetic changes in the tumor.

PROJECTED ACCRUAL: A total of 1,800 patients will be accrued for this study.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer
- Newly diagnosed or metastatic disease
Resides within the North Trent Cancer Network (NTCRN) region
Undergoing therapy at NTCRN centers
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Female
Menopausal status not specified

PRIOR CONCURRENT THERAPY:

No concurrent participation in another genetic study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463034

Locations

United Kingdom, England
University of Sheffield School of Medicine and Biomedical Sciences
Sheffield, England, United Kingdom, S10 2RX

Sponsors and Collaborators

University of Sheffield

Investigators

Study Chair:

Angela Cox, PhD

University of Sheffield

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000540737, SHEFF-05/Q2308/15, SHEFF-USMS-05/Q2308/15, EU-20726, SHEFF-STH13824, SHEFF-106364, GENFABRCA
Study First Received:	April 18, 2007
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00463034
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV breast cancer
stage I breast cancer
stage II breast cancer

stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:

Skin Diseases
Disease Progression
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009