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: December 17, 2013
Last verified: November 2008

April 18, 2007
December 17, 2013
April 2005
March 2008   (final data collection date for primary outcome measure)
Correlation of inherited and acquired variations in candidate genes with breast cancer progression and survival [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00463034 on ClinicalTrials.gov Archive Site
Establishment of a repository of blood and tumor samples [ Designated as safety issue: No ]
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Genes That Affect Disease Progression in Women With Newly Diagnosed or Metastatic Breast Cancer
Genetic Factors Affecting Breast Cancer Progression

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.

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.

Observational
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1800
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March 2008   (final data collection date for primary outcome measure)

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
Female
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No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00463034
CDR0000540737, SHEFF-05/Q2308/15, SHEFF-USMS-05/Q2308/15, EU-20726, SHEFF-STH13824, SHEFF-106364, GENFABRCA
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University of Sheffield
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Study Chair: Angela Cox, PhD University of Sheffield
National Cancer Institute (NCI)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP