Biomarkers Sample Clauses

Biomarkers. Blood biomarkers including C-reactive protein, adiponectin, and fibrinogen will be evaluated at baseline (Visit 2) and end of treatment (Visit 17 or study withdrawal). All post-screening biomarker results will be blinded to investigators and sponsor.

Biomarkers. Currently, there is a critical need for biomarkers of prostate cancer that can distinguish between locally indolent and metastatically aggressive disease191. The only FDA approved biomarker, prostate specific antigen (PSA), has historically been used for screening and detection of prostate cancer, but not for prognosis nor detection of CRPC. A major issue with PSA is that it detects prostate cells, not prostate cancer cells, and thus can result in over diagnosis and over treatment. While results of the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial showed no reduction in prostate cancer specific mortality when comparing systematic annual PSA screening to opportunistic screening192, the European Randomized Study of Screening for Prostate Cancer (ERPSC) found a small reduction in mortality (1 death per 1000 men screened) in a PSA-screening naïve population193. However, several potential flaws in the ERPSC study194 and the associated ▇▇▇▇▇ of over diagnosis and over treatment led the US Preventive Services Task Force (USPSTF) to recommend against PSA screening195, 196. Given the recent controversy in its screening effectiveness, PSA is now recommended primarily for the determination of prostate cancer progression and recurrence. However, there are potential replacements for PSA for detection screening under development, including PCA3 and the ETS fusion gene TMPRSS2-ERG197, 198, 199, 200, 201, 202, 203. TMPRSS2-ERG has been shown to be a predictive indicator of prostate cancer development in patients who present with high-grade prostatic intraepithelial neoplasia200. FISH analyses of CRPC and metastatic prostate cancers found that TMPRSS2-ERG was detected more often in metastatic cancer, and that TMPRSS2-ERG positivity was strongly correlated to both AR and ERG expression201. TMPRSS2-ERG expression has also been seen in otherwise histologically benign radical prostatectomy as well as in cystoprostatectomy specimens. TMPRSS2-ERG and PCA3 can also be detected in patient urine post-digital rectal exam204. However, there are still conflicting data regarding the prognostic value of PCA3 or TMPRSS2-ERG. A 2011 study by ▇▇▇▇▇▇ et al. found that the TMPRSS2-ERG fusion gene could be accurately assayed in circulating prostate tumor cells present in the blood of CRPC patients, but did not show that the presence of the fusion was a significant factor in abiraterone acetate treatment response198. Another prospective study of 322 patients illustrated...

Biomarkers. Biomarkers in SLE are often used for diagnosis but do not always correlate with changes in disease activity. The following biomarkers will be evaluated to determine if a change in level correlates with a change in disease activity: anti-dsDNA Ab, anti–U1-70K snRNP Ab, ANA, anti-Sm Ab, and C3, C4, CRP, IgG, IgM, IgA and IgE.

Biomarkers. Biomarkers are measurable factors of normal biological or pathogenic processes and are studied for a better understanding of biologic pathways in the tumor. Moreover, biomarkers can be studied for their prognostic value, i.e. prognosis of patient outcome like disease recurrence or survival, and/or predictive value, describing the potential of therapy response (6, 7). A prognostic biomarker is not by definition a predictive biomarker, or vice versa. However, hurdles must be overcome and criteria must be fulfilled before a new biomarker can be implemented in clinical (pathology) practice. Adequate robustness, reproducibility and validity are required, for instance. A biomarker is preferably validated in a prospective setting, ideally multicenter, with quality control during the process (7, 8). Moreover, publication of an accurate description of the methods, including laboratory techniques and/ or scoring protocols, is highly recommended (7). The last decades, it has become more clear that the tumor microenvironment, or tumor- stroma, plays an important role in tumor development and progression. A novel biomarker which has been discovered, defined, and which takes the tumor microenvironment into account is the tumor-stroma ratio (TSR). This biomarker is based on the amount of stroma in the primary tumor and has shown to be an independent prognosticator for disease- free and overall survival in various epithelial cancer types, including colon cancer (9-11). The TSR scoring method is based on the amount of stroma in relation to the amount of tumor epithelial cells, is robust and has been is described in detail (12). The experienced pathologists can easily score the TSR in daily routine on diagnostic hematoxylin and eosin (H&E) stained tissue slide sections of the carcinoma in 1-2 minutes through conventional microscopy. The amount of stroma is scored in increments of 10 percent, and tumors are subsequently categorized in two groups based: stroma-low tumors, with 50% or less stroma, and stroma-high tumors, containing more than 50% stroma. This categorization is based on risk stratification, in which patients with stroma-high tumors have a worse disease-free and overall survival (11, 12). To meet the requirements for implementation of the TSR as a new biomarker into clinical practice, the UNITED study (Uniform Noting for International application of the Tumor- stroma ratio as Easy Diagnostic tool) was initiated. In Chapter 2, the published UNITED study protocol i...

Biomarkers. For diabetic subjects, we expect a significant reduction of HGT respect to baseline after ▇▇▇▇▇▇ trial. A similar significant reduction trend we will expect for dyslipidemic participants (defined as LDL > 130 mg/dL or 3.37 mmol/L, Total Cholesterol > 200 mg/dL or 5.18 mmol/L).

Biomarkers. Please see Section 8.6 for details of total Cu, ceruloplasmin, ceruloplasmin-bound Cu, and toxic copper as measured by LBC and/or NCC, and Section 8.7 for details of Cu measured in food, drink, urine, and feces.