Studying Blood and Tumor Tissue Samples in Women With Invasive Breast Cancer, Ductal or Lobular Carcinoma in Situ, or Benign Breast Disease
- Conditions
- Breast Cancer
- Interventions
- Genetic: gene expression analysisGenetic: mutation analysisGenetic: proteomic profilingGenetic: reverse transcriptase-polymerase chain reactionOther: fluorescent antibody techniqueOther: immunohistochemistry staining methodOther: liquid chromatographyOther: laboratory biomarker analysisOther: medical chart reviewOther: mass spectrometryProcedure: quality-of-life assessment
- Registration Number
- NCT00898508
- Lead Sponsor
- City of Hope Medical Center
- Brief Summary
RATIONALE: Collecting and storing samples of blood and tumor tissue from patients with cancer to test in the laboratory may help the study of cancer in the future.
PURPOSE: This clinical trial is studying blood and tumor tissue samples in women with invasive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or benign breast disease.
- Detailed Description
OBJECTIVES:
Primary
* To establish a specimen bank from peripheral blood specimens collected from women with a full spectrum of breast disease (invasive breast cancer \[IBC\], ductal or lobular carcinoma in situ \[CIS\], or benign breast disease \[BBD\]) with standardized clinical follow up and serial specimen collection for those with IBC.
* To determine the ability of quantitative real-time reverse-transcriptase PCR (qRT-PCR) to discriminate between patients with IBC, CIS, and BBD by comparing baseline assay values from pre-biopsy specimens to the histologic diagnosis.
* To determine the ability of qRT-PCR to predict treatment response by comparing serial assay values from patients with evaluable IBC to their objective response.
* To determine the ability of qRT-PCR to predict relapse by comparing the serial assay values from all patients with IBC to their disease status.
* To determine the ability of qRT-PCR to perform as an independent prognostic factor by comparing baseline assay values from all patients with IBC to their disease status, stratified by known breast cancer prognostic factors.
Secondary
* To perform exploratory studies identifying potential targets for novel nucleic acid and proteomic-based early detection assays.
OUTLINE: Patients undergo baseline peripheral blood specimen collection pre-biopsy and then periodically for up to 10 years. Specimens are analyzed for circulating tumor cells via quantitative real-time reverse-transcriptase PCR, immunofluorescence, and bidirectional pyrophosphorolysis-activated polymerization allele-specific amplification; and for protein profiles via mass spectometry, liquid chromatography, enzyme digestion, and tandem mass spectometry. Patients' tumor tissue (invasive breast cancer \[IBC\] only) is analyzed for p53 via IHC. Medical records are reviewed periodically.
Patients with IBC complete a quality of life assessment at baseline and every 6 months for up to 10 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 563
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Invasive breast cancer medical chart review - Invasive breast cancer liquid chromatography - Normal benign breast disease or ductal carcinoma in situ liquid chromatography - Normal benign breast disease or ductal carcinoma in situ gene expression analysis - Normal benign breast disease or ductal carcinoma in situ laboratory biomarker analysis - Normal benign breast disease or ductal carcinoma in situ mutation analysis - Normal benign breast disease or ductal carcinoma in situ proteomic profiling - Normal benign breast disease or ductal carcinoma in situ immunohistochemistry staining method - Normal benign breast disease or ductal carcinoma in situ reverse transcriptase-polymerase chain reaction - Normal benign breast disease or ductal carcinoma in situ fluorescent antibody technique - Invasive breast cancer gene expression analysis - Invasive breast cancer mutation analysis - Invasive breast cancer quality-of-life assessment - Normal benign breast disease or ductal carcinoma in situ mass spectrometry - Invasive breast cancer proteomic profiling - Invasive breast cancer fluorescent antibody technique - Invasive breast cancer laboratory biomarker analysis - Normal benign breast disease or ductal carcinoma in situ medical chart review - Normal benign breast disease or ductal carcinoma in situ quality-of-life assessment - Invasive breast cancer reverse transcriptase-polymerase chain reaction - Invasive breast cancer mass spectrometry -
- Primary Outcome Measures
Name Time Method Ability of the quantitative real-time reverse-transcriptase PCR (qRT-PCR) to distinguish between biopsy benign and malignant results 5 years Ability of the qRT-PCR to predict treatment response 5 years Ability of the qRT-PCR to perform as an independent prognostic factor 5 years Ability of the qRT-PCR to predict relapse 5 years Establishment of a specimen bank 5 Years of specimen collection
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
City of Hope Medical Group
🇺🇸Pasadena, California, United States
Tower Cancer Research Foundation
🇺🇸Beverly Hills, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States