Studying Blood and Tumor Tissue Samples in Women With Invasive Breast Cancer, Ductal or Lobular Carcinoma in Situ, or Benign Breast Disease
Recruitment status was Recruiting
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.
Genetic: gene expression analysis
Genetic: mutation analysis
Genetic: proteomic profiling
Genetic: reverse transcriptase-polymerase chain reaction
Other: fluorescent antibody technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: liquid chromatography
Other: mass spectrometry
Other: medical chart review
Procedure: quality-of-life assessment
|Official Title:||Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up|
- Establishment of a specimen bank [ Designated as safety issue: No ]
- Ability of the quantitative real-time reverse-transcriptase PCR (qRT-PCR) to distinguish between biopsy benign and malignant results [ Designated as safety issue: No ]
- Ability of the qRT-PCR to predict treatment response [ Designated as safety issue: No ]
- Ability of the qRT-PCR to predict relapse [ Designated as safety issue: No ]
- Ability of the qRT-PCR to perform as an independent prognostic factor [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|United States, California|
|Tower Cancer Research Foundation||Recruiting|
|Beverly Hills, California, United States, 90211|
|Contact: Solomon I. Hamburg, MD, PhD 310-888-8680|
|City of Hope Comprehensive Cancer Center||Recruiting|
|Duarte, California, United States, 91010-3000|
|Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 firstname.lastname@example.org|
|City of Hope Medical Group||Recruiting|
|Pasadena, California, United States, 91105|
|Contact: Mark V. McNamara, MD 626-396-2900 email@example.com|
|Principal Investigator:||Melanie R. Palomares, MD, MS||Beckman Research Institute|