Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up
- 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.
Establishment of a specimen bank
Melanie R. Palomares, MD, MS
Beckman Research Institute
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|City of Hope Medical Group||Pasadena, California 91105|
|Tower Cancer Research Foundation||Beverly Hills, California 90211|