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

Breast Cancer Clinical Trial

Official title:

Genetic Factors Affecting Breast Cancer Progression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00463034
• Other study ID #: CDR0000540737
• Secondary ID: SHEFF-05/Q2308/1
• Status: Active, not recruiting
• Phase: N/A
• First received: April 18, 2007
• Last updated: December 17, 2013
• Start date: April 2005

Study information

• Verified date: November 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1800
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• microarray analysis

• polymerase chain reaction

• polymorphism analysis

Other:
• high performance liquid chromatography

• immunohistochemistry staining method

• laboratory biomarker analysis

• questionnaire administration

Locations

Country	Name	City	State
United Kingdom	University of Sheffield School of Medicine and Biomedical Sciences	Sheffield	England

Sponsors (1)

Lead Sponsor	Collaborator
University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of inherited and acquired variations in candidate genes with breast cancer progression and survival			No
Secondary	Establishment of a repository of blood and tumor samples			No