Genes That Affect Disease Progression in Women With Newly Diagnosed or Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
microarray analysis
polymerase chain reaction
polymorphism analysis
high performance liquid chromatography
immunohistochemistry staining method
laboratory biomarker analysis
questionnaire administration
Sponsored by
About this trial
This is an observational trial for Breast Cancer focused on measuring stage IV breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Eligibility 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
Sites / Locations
- University of Sheffield School of Medicine and Biomedical Sciences
Outcomes
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
Full Information
NCT ID
NCT00463034
First Posted
April 18, 2007
Last Updated
December 17, 2013
Sponsor
University of Sheffield
1. Study Identification
Unique Protocol Identification Number
NCT00463034
Brief Title
Genes That Affect Disease Progression in Women With Newly Diagnosed or Metastatic Breast Cancer
Official Title
Genetic Factors Affecting Breast Cancer Progression
Study Type
Observational
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2008 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sheffield
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
7. Study Design
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
microarray analysis
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Other
Intervention Name(s)
high performance liquid chromatography
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Correlation of inherited and acquired variations in candidate genes with breast cancer progression and survival
Secondary Outcome Measure Information:
Title
Establishment of a repository of blood and tumor samples
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Cox, PhD
Organizational Affiliation
University of Sheffield
Official's Role
Study Chair
Facility Information:
Facility Name
University of Sheffield School of Medicine and Biomedical Sciences
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2RX
Country
United Kingdom
12. IPD Sharing Statement
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Genes That Affect Disease Progression in Women With Newly Diagnosed or Metastatic Breast Cancer
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