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Genes That Affect Disease Progression in Women With Newly Diagnosed or Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00463034
First received: April 18, 2007
Last updated: February 14, 2009
Last verified: November 2008
History of Changes
  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
 Genetic: microarray analysis
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: high performance liquid chromatography
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: questionnaire administration

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

Resource links provided by NLM:

U.S. FDA Resources

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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00463034     History of Changes
Other 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: February 14, 2009
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

Additional relevant MeSH terms:
Breast Neoplasms
Disease Progression
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013