NCT00463034

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Last Updated

December 18, 2013

Status Verified

November 1, 2008

Enrollment Period

2.9 years

First QC Date

April 18, 2007

Last Update Submit

December 17, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

  • Correlation of inherited and acquired variations in candidate genes with breast cancer progression and survival

Secondary Outcomes (1)

  • Establishment of a repository of blood and tumor samples

Interventions

microarray analysisGENETIC
polymerase chain reactionGENETIC
polymorphism analysisGENETIC
high performance liquid chromatographyOTHER
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER
questionnaire administrationOTHER

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Sheffield School of Medicine and Biomedical Sciences

Sheffield, England, S10 2RX, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Microarray AnalysisPolymerase Chain ReactionAmplified Fragment Length Polymorphism AnalysisChromatography, High Pressure LiquidImmunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesNucleic Acid Amplification TechniquesGenetic TechniquesDNA FingerprintingChromatography, LiquidChromatographyChemistry Techniques, AnalyticalHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • Angela Cox, PhD

    University of Sheffield

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 19, 2007

Study Start

April 1, 2005

Primary Completion

March 1, 2008

Last Updated

December 18, 2013

Record last verified: 2008-11

Locations

GB(1)