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Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up
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.
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.
Age
20 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Tower Cancer Research Foundation
Beverly Hills, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
City of Hope Medical Group
Pasadena, California, United States
Start Date
August 1, 2005
Primary Completion Date
June 6, 2019
Completion Date
June 6, 2019
Last Updated
June 25, 2025
563
ACTUAL participants
gene expression analysis
GENETIC
mutation analysis
GENETIC
proteomic profiling
GENETIC
reverse transcriptase-polymerase chain reaction
GENETIC
fluorescent antibody technique
OTHER
immunohistochemistry staining method
OTHER
laboratory biomarker analysis
OTHER
liquid chromatography
OTHER
mass spectrometry
OTHER
medical chart review
OTHER
quality-of-life assessment
PROCEDURE
Lead Sponsor
City of Hope Medical Center
Collaborators
NCT05673200
NCT05372640
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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