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

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ClinicalTrials.gov Identifier: NCT00463034
Recruitment Status : Unknown
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : April 19, 2007
Last Update Posted : December 18, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
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

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.


Study Design

Study Type : Observational
Estimated Enrollment : 1800 participants
Official Title: Genetic Factors Affecting Breast Cancer Progression
Study Start Date : April 2005
Estimated Primary Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Correlation of inherited and acquired variations in candidate genes with breast cancer progression and survival

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 19, 2007    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: November 2008

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
Neoplasms
Breast Diseases
Skin Diseases