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    Research Grants Awarded

    Salivary Diagnostics To Identify And Diagnose Breast Cancer

    Grant Mechanism:
    Investigator Initiated Research

    Scientific Abstract:
    Biomarker research has benefited considerably from current technological advances. As this is a burgeoning field, there are numerous studies using protein profiling for the detection of cancer. Studies using serum as a diagnostic medium have yielded putative markers for bladder, prostate, lung, ovarian, and breast cancers. However, to date, no such analyses have been performed with saliva, in order to ascertain if this readily collectable fluid has diagnostic utility. We hypothesize that the protein patterns in saliva from patients diagnosed with breast cancer will be significantly different in comparison with the salivary protein patterns of healthy women and with those women diagnosed with benign breast tumors. The aim of this study is to validate a panel of salivary proteins that will uniquely characterize and differentiate between individuals that are healthy (Group 1), subjects (Group 2) diagnosed with fiboradenoma tumors, women (Group 3) diagnosed with invasive ductal carcinoma of the breast Stage 1 (IDC) and the same women (Group 4) diagnosed with IDC one year after treatment and in remission. Robust statistical analyses will be performed on the resultant data to determine the decision boundary (cut point) and sensitivity/specificity (ROC curves) of each individual marker, different combinations of markers and as a panel of markers in order to optimize the ability to detect breast cancer. If the hypothesis is correct, Groups 1, 2 & 4 should possess statistically equivalent mean values. If successful, these markers could be developed into non-invasive diagnostic tests which 1) could serve as an adjunct test to mammography thus reducing the number of false positives experienced in this type of imaging, 2) could monitor the efficacy of current chemotherapy regimens; and 3) could monitor disease recurrence - all of which would reduce morbidity and mortality rates for breast cancer and thereby reduce national health care expenditures.

    Lay Abstract:
    Protein markers as a diagnostic tool for cancer and other diseases have been studied for several years. In the medical community, studies using blood as a diagnostic medium have yielded presumed markers for bladder, prostate, ovarian, lung, and breast cancers. However, to date, no such analyses have been performed with saliva to ascertain if this readily collectable fluid has similar or greater diagnostic utility. We hypothesize that protein patterns in saliva from patients diagnosed with breast cancer will be significantly different and predictable in comparison with the salivary protein patterns of healthy women and those diagnosed with benign breast tumors. The goal of this study is to validate a panel of salivary proteins that will uniquely characterize and differentiate between individuals that are healthy, have benign breast tumors and have carcinoma of the breast. This will be accomplished by comparing concentrations from eight selected proteins among three groups of women. The three groups of women will be a healthy control group, subjects diagnosed with benign tumors and women diagnosed with cancer of the breast. Statistical analyses will be performed to determine the usefulness of each individual marker, different combinations of markers and as a panel of markers in order to optimize the ability to detect breast cancer. At present, Dr. Streckfus and his collaborators have discovered eight cancer-related proteins in saliva that are altered in the presence of infiltrating ductal carcinoma (breast cancer cells, or IDC). This study will determine the ability (both sensitivity and specificity) of these biomarkers to detect IDC. Once the best combination of these biomarkers are determined for their diagnostic efficacy, the next step will be a large clinical trial whereby salivary samples will be applied to an already-existing diagnostic microchip detector that will serve as a platform to determine the presence of IDC. If successful, these markers could be developed into a non-invasive diagnostic test which could - -Serve as a preliminary and non-invasive test prior to mammography and other current diagnostic procedures -Monitor the efficacy of current chemotherapy regimens, and -Monitor disease recurrence among affected patients All of which would reduce morbidity and mortality rates for breast cancer and thereby reduce national health care expenditures. If successful, there is a logical progression of study that would provide similar early diagnosis and detection of other related cancers (testicular, ovarian, head and neck, brain, cervical). The proposed work is innovative because it may develop into new methodologies for early and pre-emptive cancer detection which fulfills the mission of limiting and/or eradicating breast and other cancers as a life threatening disease.