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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. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: April 18, 2007
Last updated: December 17, 2013
Last verified: November 2008

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:

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

Secondary Outcome Measures:
  • Establishment of a repository of blood and tumor samples

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



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


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • Female
  • Menopausal status not specified


  • No concurrent participation in another genetic study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00463034

United Kingdom
University of Sheffield School of Medicine and Biomedical Sciences
Sheffield, England, United Kingdom, S10 2RX
Sponsors and Collaborators
University of Sheffield
Study Chair: Angela Cox, PhD University of Sheffield
  More Information Identifier: NCT00463034     History of Changes
Other Study ID Numbers: CDR0000540737
Study First Received: April 18, 2007
Last Updated: December 17, 2013

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
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on September 21, 2017