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

Tracking Information

First Received Date ^ICMJE

April 18, 2007

Last Updated Date

February 14, 2009

Start Date ^ICMJE

April 2005

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Correlation of inherited and acquired variations in candidate genes with breast cancer progression and survival [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00463034 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Establishment of a repository of blood and tumor samples [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Genetic Factors Affecting Breast Cancer Progression

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

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 Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1800

Completion Date

Not Provided

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00463034

Other Study ID Numbers ^ICMJE

CDR0000540737, SHEFF-05/Q2308/15, SHEFF-USMS-05/Q2308/15, EU-20726, SHEFF-STH13824, SHEFF-106364, GENFABRCA

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Sheffield

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Angela Cox, PhD

University of Sheffield

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2008

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

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